Interacciones de los nuevos inhibidores de la proteasa para el tratamiento de la hepatitis C: telaprevir y boceprevir / Systematic review of new protease inhibitors interactions: telaprevir and boceprevir

Introducción: Los nuevos inhibidores de la proteasa (IPs), telaprevir y boceprevir, con peginterferón y ribavirina, han aumentado la tasa de respuesta en pacientes con el Virus de la Hepatitis C genotipo 1. Ambos son metabolizados y son inhibidores del CYP3A y sustratos, y telaprevir inhibidor, de la glicoproteína P. Nuestro objetivo es analizar las interacciones entre estos IPs y otros medicamentos. Métodos: Se realizó una revisión sistematizada en PubMed y Cochrane y en resúmenes de congresos (últimos 2-5 años). Se realizó otra búsqueda en Medline para revisar artículos de eficacia en fase II y III, en Micromedex y fichas técnicas. Resultados: En PubMed se encontraron dos artículos sobre ensayos en fase I que cumplían los criterios de búsqueda, no así en las bases de datos de la Cochrane. Se seleccionaron catorce resúmenes de congresos, mayoritariamente estudios en fase I. En la búsqueda libre en Pubmed se localizó un ensayo preclínico in vitro/in vivo que analizaba IPs coadministrados con ritonavir. En los ensayos clínicos en fase II y III, no se hizo ninguna mención sobre interacciones. Conclusiones: Actualmente, disponemos de estudios en fase I que establecen la alteración de parámetros farmacocinéticos al combinar los IPs con medicamentos representativos (potentes inductores, potentes inhibidores, fármacos con alta unión a proteínas plasmáticas, etc.), existiendo evidencias contradictorias de estas interacciones. Su incorporación a la terapéutica debe tener en cuenta la posibilidad de interacciones complejas y no del todo conocidas, en cuanto a su mecanismo de acción, que pudieran comprometer su eficacia o incrementar su toxicidad (AU)

Introduction: The new protease inhibitors (PIs), telaprevir and boceprevir, with peginterferon and ribavirin, have increased the response rate in patients with genotype 1 chronic hepatitis C. Both are metabolized by CYP3A and they are CYP3A inhibitors. Furthermore, they are substrates, also telaprevir is an inhibitor, for P-glycoprotein. Our aim is to analyze the interactions between these IPs and other medications. Method: We performed a systematic review in PubMed and Cochrane database and in conference abstracts of the last 2-5 years. Another search was performed in Medline to check efficacy clinical trials in phase II and III, in Micromedex database and in label information. Results: In PubMed we found two Phase I clinical trials; we did not find any article in the Cochrane database. 14 conference abstracts were selected, mainly there are phase I studies. In the free search in PubMed was located an in vitro / in vivo preclinical study which analyzed the co-administration of IPs and ritonavir. In phase II and III clinical trials, there was no mention about interactions. Conclusions: Currently, there are pharmacokinetic Phase I studies about the interaction between PIs and representative drugs (potent inducers, potent inhibitors, high protein binding drugs, etc.), but the evidence of these interactions is contradictory. Its incorporation into the therapeutic have to take into account the possibility of complex interactions and not entirely known, about their mechanism of action, which might compromise its effectiveness or increase its toxicity (AU)

[Systematic review of new protease inhibitors interactions: telaprevir and boceprevir]. / Interacciones de los nuevos inhibidores de la proteasa para el tratamiento de la hepatitis C: telaprevir y boceprevir.

INTRODUCTION: The new protease inhibitors (PIs), telaprevir and boceprevir, with peginterferon and ribavirin, have increased the response rate in patients with genotype 1 chronic hepatitis C. Both are metabolized by CYP3A and they are CYP3A inhibitors. Furthermore, they are substrates, also telaprevir is an inhibitor, for P-glycoprotein. Our aim is to analyze the interactions between these IPs and other medications. METHOD: We performed a systematic review in PubMed and Cochrane database and in conference abstracts of the last 2-5 years. Another search was performed in Medline to check efficacy clinical trials in phase II and III, in Micromedex database and in label information. RESULTS: In PubMed we found two Phase I clinical trials; we did not find any article in the Cochrane database. 14 conference abstracts were selected, mainly there are phase I studies. In the free search in PubMed was located an in vitro / in vivo preclinical study which analyzed the co-administration of IPs and ritonavir. In phase II and III clinical trials, there was no mention about interactions. CONCLUSIONS: Currently, there are pharmacokinetic Phase I studies about the interaction between PIs and representative drugs (potent inducers, potent inhibitors, high protein binding drugs, etc.), but the evidence of these interactions is contradictory. Its incorporation into the therapeutic have to take into account the possibility of complex interactions and not entirely known, about their mechanism of action, which might compromise its effectiveness or increase its toxicity.

Desarrollo, implantación y evaluación de un programa de prescripción electrónica asistida de medicamentos en un hospital / Development, implementation and evaluation of an electronic drug prescribing program in a hospital

Objetivo: Desarrollar e implantar herramientas seguras y eficaces para la prescripción electrónica de los tratamientos farmacológicos. Material y método: Se realizó una revisión bibliográfica para cada medicamento o principio activo incluido en la Guía Farmacoterapéutica del Hospital para recoger información acerca de sus interacciones y ajustes posológicos en insuficiencia renal. Se elaboró una base de datos con 62 interacciones clínicamente relevantes y otra de 531 fármacos con recomendaciones posológicas o de monitorización en función del grado de insuficiencia renal (IR). Resultados: La integración de la base de datos de IR permite que desde el Servicio de Farmacia se pueda seleccionar a los pacientes con alteración en la función renal que tienen prescritos medicamentos que requieren ajuste posológico y asesorar sobre las recomendaciones individualizadamente, incorporando esta información a la historia clínica electrónica. Conclusión: esta herramienta, ha mejorado el programa de prescripción electrónica, convirtiéndolo en una prescripción electrónica asistida (AU)

Objetive: Develop and implement safe and effective tools for computer provider order entry to serve as clinical decision support. Material and methods: A literature review was performed for each drug included in the Hospital's pharmaceutical guide for collecting information on clinically relevant drug interactions and dose adjustments in renal failure Results: A database with 62 clinically relevant interactions was developed and integrated into the hospital information program. When an interaction is detected at the time of prescribing an alert is generated to report on its consequences and alternatives. Another database with 531 drugs with dosing or monitoring recommendations specific to the degree of renal failure in each patient was developed and integrated into the hospital information system, so that from the Pharmacy Department we can select patients with impaired renal function who have been prescribed drugs that require dose adjustment and advise on the dosage recommendations for each patient. Conclusion: Due to the development and implementation of these tools, we have improved our computer provider order entry with a clinical decision support system (AU)

Meta-análisis sobre la eficacia de la estrategia de monoterapia con inhibidores de la proteasa potenciados en pacientes VIH+ / Meta-analysis of the effectiveness of the strategy of monotherapy with boosted protease inhibitors in HIV+ patients

Introducción El objetivo del presente trabajo es analizar la evidencia disponible sobre la eficacia de la estrategia de inducción mantenimiento con inhibidores de proteasa potenciados con ritonavir en pacientes adultos VIH respecto al tratamiento convencional. Métodos Se realizó un meta-análisis de ensayos aleatorizados y controlados en pacientes VIH para comparar la eficacia de una estrategia de monoterapia con inhibidores de proteasa potenciados frente al tratamiento antirretroviral convencional. La búsqueda bibliográfica se realizó en PubMed, EMBASE (septiembre 1999–septiembre 2009) y en resúmenes de congresos de los últimos 5 años. Se calcularon los Odds Ratio del fracaso terapéutico y sus intervalos de confianza del 95%. Para combinar los resultados de los estudios individuales seleccionados, se empleó un modelo de efectos fijos basado en el método de Mantel-Haenszel o de efectos aleatorios, en función de que exista o no heterogeneidad en los resultados. Resultados Se localizaron inicialmente un total de 1.510 publicaciones, de las que solo 8 estudios cumplieron los criterios de inclusión en el meta-análisis. El Odds Ratio combinado de los 8 estudios es de 1,39 (IC 95% 1,02–1,90) a favor del grupo de tratamiento con tratamiento antirretroviral convencional, pero con un intervalo de confianza cercano a los límites de la no significación estadística. Conclusión Los resultados del análisis de eficacia combinado en el meta-análisis no encuentran diferencias significativas entre la estrategia convencional y la monoterapia. Esta estrategia se considera recomendable (nivel A de evidencia) en pacientes sin historia de fracaso previo a inhibidores de la proteasa, con carga viral plasmática indetectable y signos o síntomas de toxicidad por análogos de nucleósidos/nucleótidos (AU)

Introduction The objective of this study is to analyse the available evidence regarding the effectiveness of the strategy of induction maintenance with boosted protease inhibitors with ritonavir in adult HIV patients as compared to conventional treatment. Methods We performed a meta-analysis of randomised controlled trials in HIV patients to compare the efficacy of a monotherapy strategy of boosted protease inhibitors as compared with conventional antiretroviral therapy. The literature search was conducted in PubMed, EMBASE (September 1999–September 2009) and in conference abstracts of the last 5 years. The Odds Ratio of treatment failure and their 95% confidence intervals were calculated. To combine the results of individual studies selected, a fixed effects model based on the Mantel-Haenszel method or random effects was used, depending on whether or not the results were heterogeneous. Results Initially a total of 1510 publications were found, of which just 8 studies met the criteria for inclusion in the meta-analysis. The combined Odds Ratio of the 8 studies is 1.39 (95% CI 1.02–1.90) for the treatment group with conventional antiretroviral treatment, but with a confidence interval close to the limits of statistical non-significance. Conclusion The results of the combined effectiveness analysis in the meta-analysis found no significant differences between the conventional strategy and monotherapy. This strategy is considered recommended (level A evidence) in patients with no history of previous failure of protease inhibitor, with undetectable plasma viral load and signs or symptoms of nucleoside/nucleotide toxicity (AU)

[Meta-analysis of the effectiveness of the strategy of monotherapy with boosted protease inhibitors in HIV+ patients]. / Meta-análisis sobre la eficacia de la estrategia de monoterapia con inhibidores de la proteasa potenciados en pacientes VIH+

INTRODUCTION: The objective of this study is to analyse the available evidence regarding the effectiveness of the strategy of induction maintenance with boosted protease inhibitors with ritonavir in adult HIV patients as compared to conventional treatment. METHODS: We performed a meta-analysis of randomised controlled trials in HIV patients to compare the efficacy of a monotherapy strategy of boosted protease inhibitors as compared with conventional antiretroviral therapy. The literature search was conducted in PubMed, EMBASE (September 1999-September 2009) and in conference abstracts of the last 5 years. The Odds Ratio of treatment failure and their 95% confidence intervals were calculated. To combine the results of individual studies selected, a fixed effects model based on the Mantel-Haenszel method or random effects was used, depending on whether or not the results were heterogeneous. RESULTS: Initially a total of 1510 publications were found, of which just 8 studies met the criteria for inclusion in the meta-analysis. The combined Odds Ratio of the 8 studies is 1.39 (95% CI 1.02-1.90) for the treatment group with conventional antiretroviral treatment, but with a confidence interval close to the limits of statistical non-significance. CONCLUSION: The results of the combined effectiveness analysis in the meta-analysis found no significant differences between the conventional strategy and monotherapy. This strategy is considered recommended (level A evidence) in patients with no history of previous failure of protease inhibitor, with undetectable plasma viral load and signs or symptoms of nucleoside/nucleotide toxicity.

Características psicométricas de la escala de satisfacción con el / tratamiento antirretroviral (ESTAR): estudio ARPAS (I) / No disponible

Objetivo: Evaluar las características psicométricas, la validez convergente y la fiabilidad de la escala de satisfacción con el tratamientoantirretroviral (ESTAR).Método: La satisfacción de los pacientes con el TAR se determinó mediante la ESTAR, desarrollada en castellano a partir de la versióninglesa HIV-Treatment-Satisfaction-Questionnaire (HIVTSQ).Para su evaluación, se midió la consistencia interna y la fiabilidad test-retest. Se efectuó el análisis de constructo estudiando la covarianzay la correlaciones de las cuestiones, y se valoró la validez convergente empleando como estándar el cuestionario MOS-HIV (MedicalOutcomes Study HIV Health Survey), y la validez de contenido mediante la correlación entre la ESTAR y las variables clínicas y terapéuticas.Resultados: La ESTAR se estructura en dos dimensiones (desatisfacción clínica y de satisfacción con el estilo de vida) con ligeras modificaciones sobre la versión original; la cuestión 4, desechada en la versión original, es reformulada en la versión española, y la cuestión 9 se extrajo por su baja comunalidad. Respecto a la fiabilidad test-retest, todos las cuestiones presentan coeficientes de correlación intraclase significativos (p < 0,001). La consistencia interna presenta valores más altos que la versión original en la dimensión estilo de vida (α = 0,81 frente a α = 0,74) y en la puntuación total (α = 0,84 frente a α = 0,82). Respecto a la validezconvergente, la ESTAR presenta correlaciones significativas con la totalidad y con diversas dimensiones del MOS-HIV, destacando la asociación con las dimensiones salud mental, problemas de salud y función cognitiva.Conclusiones: La ESTAR se muestra como un instrumentoadecuado y fiable para evaluar la satisfacción con el TAR de los pacientes infectados por el VIH

Objective: To evaluate the psychometric characteristics, convergent validity and reliability of the antiretroviral treatment satisfactionscale (ESTAR, escala de satisfacción con el tratamientoantirretroviral ).Method: Patient satisfaction with ART was determined using the ESTAR questionnaire, developed in Spanish based on the English language version of the HIV-Treatment-Satisfaction Questionnaire(HIVTSQ). In order to evaluate this, internal consistency and test-retest reliability were measured. The construct analysis was performedby studying the covariance and correlation of the questions, and the convergent validity was assessed by using the MOS-HIV (Medical Outcomes Study HIV Health Survey) questionnaire as the standard, as was the content validity by the correlation between theESTAR and the clinical and therapeutic variables.Results: The ESTAR is structured in two dimensions (clinical satisfaction and satisfaction with lifestyle) with slight modifications to the original version; question 4, discarded in the original version,has been reworded in the Spanish version, and question 9was deleted because of low communality. As regards the testretest reliability, all the questions show significant intraclass correlation coefficients (p < 0.001). The internal consistency shows higher values than the original version in the lifestyle dimension (α = 0.81 vs. α =0.74) and in the total score (α = 0.84 vs. α = 0.82). With regard to convergent validity, the ESTAR presents significant correlations with the MOS-HIV as a whole and with different imensions of it, especially the association with mental health, health distress and cognitive functioning dimensions.Conclusions: The ESTAR turns out to be a suitable, reliable instrument for evaluating satisfaction with ART by HIV+ patients

Preferencias, satisfacción y adherencia con el tratamientoantirretroviral: estudio ARPAS (II) / No disponible

Objetivo: Describir el estudio ARPAS y analizar las características sociodemográficas, clínicas y las preferencias de los pacientes con el tratamiento antirretroviral (TAR), así como la relación entrela adherencia y la satisfacción con el TAR y la calidad de vida.Método: El estudio ARPAS ha evaluado a pacientes adultos,diagnosticados de infección por VIH y con TAR, mediante un protocolo que incluye variables sociodemográficas, clínicas, terapéuticas y de calidad de vida. La adherencia se estimó mediante el cuestionarioSMAQ, la satisfacción mediante el cuestionario ESTAR, la calidad de vida mediante el MOS-HIV y las preferencias con el tratamiento se determinaron mediante un cuestionario elaborado a partir del consenso de un equipo experto en el seguimiento terapéutico de estospacientes. Se realizó un análisis univariante estratificado en funciónde la adherencia y un análisis de regresión logística para estudiar la asociación de las variables independientes con la adherencia.Resultados: Se evaluaron 234 pacientes (73,7% varones;43,2 ± 7,8 años). El tiempo medio desde el diagnóstico y desde el inicio del TAR fue, respectivamente, de 10,1 ± 5,7 y 7,4 ± 4,4 años. El régimen terapéutico de dos tomas diarias (bid) se dio en el 71% de los pacientes, y el de una toma (qd) en el 21%. El 47,3% de los pacientes cumplieron criterios de adherencia según el SMAQ. El porcentaje de los pacientes con qd adherentes alTAR fue mayor que el resto de esquemas posológicos (55,3 vs. 45,1%), aunque no significativamente (p = 0,251). No se observaron diferencias en las variables sociodemográficas y clínicas en función de la adherencia. Se observó una preferencia electivasobre los regímenes terapéuticos más sencillos que contrasta con la valoración de las características de los TAR, donde se antepone la potencia sobre la durabilidad, tolerancia y, en último lugar, comodidad de tomar el TAR. El análisis univariante muestra unamayor puntuación en las escalas de satisfacción (50,4 ± 7,8 vs.46,5 ± 9,7, p = 0,001) y calidad de vida (81,6 ± 10,7 vs. 75,7 ± 11,8, p < 0,001) en los pacientes adherentes respecto de los no adherentes. Los modelos multivariante confirman la existencia de una asociación significativa entre adherencia y satisfacción, y adherencia y calidad de vida.Conclusiones: Los pacientes consideran prioritario tratarse con un TAR potente, duradero y bien tolerado y, dentro de las preferencias entre las diferentes pautas, destacan los regímenes de una toma diaria. El estudio ARPAS demuestra la relación directa entre adherencia y satisfacción con el TAR, y entre adherencia y calidad de vida, de forma que las estrategias de mejora de la adherencia deben incluir necesariamente aspectos que permitan mejorar la satisfacción del paciente con su tratamiento e incrementarla calidad de vida

Objective: To describe the ARPAS study and analyse thesociodemographic and clinical characteristics and patient preferenceswith regards the antiretroviral treatment (ART), as well as the relationship between compliance and satisfaction with the ART and quality of life.Method: The ARPAS study has looked at adult patients diagnosed with HIV and on ART, using a protocol including sociodemographic, clinical, therapeutic and quality of life variables. Compliance was estimated using the SMAQ questionnaire; satisfactionwas measured using the ESTAR questionnaire, as was quality of life with the MOS-HIV Health Survey, and treatment preferences were determined using a questionnaire prepared based on the consensus of an expert team in the field of therapeutic monitoringof these patients. A stratified univariate analysis according to compliance and a logistic regression analysis were carried out to study the association of the independent variables with compliance.Results: A total of 234 patients were evaluated (73.7% male; 43.2 ± 7.8 years of age). The average time since diagnosis and from the initiation of ART was 10.1 ± 5.7 and 7.4 ± 4.4 years respectively.The therapeutic regime of twice-daily doses (bid) wasapplied to 71% of the patients, and once daily (qd) in 21%. A total of 43% of the patients fulfilled compliance criteria according to the SMAQ. The percentage of the patients with qd complying with theART was greater than the remaining dosing schedules (55.3 vs. 45.1%), although not significantly (p = 0.251). No differences were observed in the sociodemographic and clinical variables in terms ofcompliance. An elective preference was observed for the simplest of the therapeutic regimes which contrasts with the evaluation of the ART characteristics, where power is given preference over durability,tolerance and lastly, the convenience of taking the ART. The univariate analysis showed the highest score on the satisfaction scales (50.4 ± 7.8 vs. 46.5 ± 9.7, p = 0.001) and quality of life (81.6± 10.7 vs. 75.7 ± 11.8, p < 0.001) in compliant patients with respect to non-compliers. The multivariate models confirm the existence of a significant association between compliance and satisfaction, and between compliance and quality of life.Conclusions: Patients consider treatment with a powerful,long-lasting and well-tolerated ART a priority and among their preferences for different treatment regimes, once-daily dosing regimes are highlighted. The ARPAS study showed a direct relationship between compliance and satisfaction with ART, and between complianceand quality of life, in a manner that the strategies improving compliance must necessarily include aspects that allow them to improve patient satisfaction with treatment and quality of life

[Psychometric characteristics of the antiretroviral treatment satisfaction scale (ESTAR): ARPAS study (I)]. / Características psicométricas de la escala de satisfacción con el tratamiento antirretroviral (ESTAR): estudio ARPAS (I).

OBJECTIVE: To evaluate the psychometric characteristics, convergent validity and reliability of the antiretroviral treatment satisfaction scale (ESTAR, escala de satisfacción con el tratamiento antirretroviral). METHOD: Patient satisfaction with ART was determined using the ESTAR questionnaire, developed in Spanish based on the English language version of the HIV-Treatment-Satisfaction Questionnaire (HIVTSQ). In order to evaluate this, internal consistency and test-retest reliability were measured. The construct analysis was performed by studying the covariance and correlation of the questions, and the convergent validity was assessed by using the MOS-HIV (Medical Outcomes Study HIV Health Survey) questionnaire as the standard, as was the content validity by the correlation between the ESTAR and the clinical and therapeutic variables. RESULTS: The ESTAR is structured in two dimensions (clinical satisfaction and satisfaction with lifestyle) with slight modifications to the original version; question 4, discarded in the original version, has been reworded in the Spanish version, and question 9 was deleted because of low communality. As regards the test-retest reliability, all the questions show significant intraclass correlation coefficients (p<0.001). The internal consistency shows higher values than the original version in the lifestyle dimension (a=0.81 vs. a=0.74) and in the total score (a=0.84 vs. a=0.82). With regard to convergent validity, the ESTAR presents significant correlations with the MOS-HIV as a whole and with different dimensions of it, especially the association with mental health, health distress and cognitive functioning dimensions. CONCLUSIONS: The ESTAR turns out to be a suitable, reliable instrument for evaluating satisfaction with ART by HIV+ patients.

[Preferences, satisfaction and compliance with antiretroviral treatment: ARPAS study (II)]. / Preferencias, satisfacción y adherencia con el tratamiento antirretroviral: estudio ARPAS (II).

OBJECTIVE: To describe the ARPAS study and analyse the sociodemographic and clinical characteristics and patient preferences with regards the antiretroviral treatment (ART), as well as the relationship between compliance and satisfaction with the ART and quality of life. METHOD: The ARPAS study has looked at adult patients diagnosed with HIV and on ART, using a protocol including sociodemographic, clinical, therapeutic and quality of life variables. Compliance was estimated using the SMAQ questionnaire; satisfaction was measured using the ESTAR questionnaire, as was quality of life with the MOS-HIV Health Survey, and treatment preferences were determined using a questionnaire prepared based on the consensus of an expert team in the field of therapeutic monitoring of these patients. A stratified univariate analysis according to compliance and a logistic regression analysis were carried out to study the association of the independent variables with compliance. RESULTS: A total of 234 patients were evaluated (73.7% male; 43.2+/-7.8 years of age). The average time since diagnosis and from the initiation of ART was 10.1+/-5.7 and 7.4+/-4.4 years respectively. The therapeutic regime of twice-daily doses (bid) was applied to 71% of the patients, and once daily (qd) in 21%. A total of 43% of the patients fulfilled compliance criteria according to the SMAQ. The percentage of the patients with qd complying with the ART was greater than the remaining dosing schedules (55.3 vs. 45.1%), although not significantly (p=0.251). No differences were observed in the sociodemographic and clinical variables in terms of compliance. An elective preference was observed for the simplest of the therapeutic regimes which contrasts with the evaluation of the ART characteristics, where power is given preference over durability, tolerance and lastly, the convenience of taking the ART. The univariate analysis showed the highest score on the satisfaction scales (50.4+/-7.8 vs. 46.5+/-9.7, p=0.001) and quality of life (81.6+/-10.7 vs. 75.7+/-11.8, p<0.001) in compliant patients with respect to non-compliers. The multivariate models confirm the existence of a significant association between compliance and satisfaction, and between compliance and quality of life. CONCLUSIONS: Patients consider treatment with a powerful, long-lasting and well-tolerated ART a priority and among their preferences for different treatment regimes, once-daily dosing regimes are highlighted. The ARPAS study showed a direct relationship between compliance and satisfaction with ART, and between compliance and quality of life, in a manner that the strategies improving compliance must necessarily include aspects that allow them to improve patient satisfaction with treatment and quality of life.

[Intervention of a pharmacy department following the 11-M terrorist attack]. / Actuación de un servicio de farmacia en el atentado terrorista del 11-M.

OBJECTIVE: To describe the intervention of a pharmacy department, as well as medication requirements, in the healthcare emergency situation brought about by the terrorist attack of March 11, 2004 in Madrid. To compare this intervention with other similar experiences reported in the medical literature. METHOD: A compilation of actions carried out by pharmacists directly involved in the management of this incident. A literature search of Medline, Cochrane Library, and Spanish Index Medicus databases. RESULTS: The pharmacy department acted to ensure the availability of all medication needed in the management of casualties by placing urgent orders in pharmaceutical laboratories, simplifying distribution networks, and staying in permanent contact with the medical and nursing staff of the emergency department, as well as with people in charge of emergency coordination. Most commonly used medications included plasma expanders, fluid therapy, blood-derived products, pain killers, antiseptics, peripheral myorelaxants, and antibiotics, which are consistent with those employed by other Madrid hospitals for this same attack. CONCLUSIONS: The pharmacy department, as any other department in a hospital, should be ready to rapidly and effectively cope with any emergency situation. Having a protocol available including major intervention guidelines is advisable to reduce reaction times, anticipate potential complications, and effectively solve such situations.

Actuación de un servicio de farmacia en el atentado terrorista del 11-M / No disponible

Objetivo: Describir la actuación del servicio de farmacia asícomo la demanda de medicamentos en la situación de emergenciasanitaria provocada por el atentado terrorista del 11 de marzo de2004 en Madrid. Comparar esta actuación con otras experienciassimilares publicadas en la literatura médica.Método: Recopilación de las acciones llevadas a cabo por losfarmacéuticos implicados directamente en la gestión del suceso.Búsqueda bibliográfica en las bases de datos Medline, CochraneLibrary e Índice Médico Español.Resultados: La actuación del servicio de farmacia se basó engarantizar la disponibilidad de los medicamentos necesarios parael tratamiento de los heridos realizando pedidos urgentes a loslaboratorios, simplificando los circuitos de distribución y manteniendocomunicación permanente con el personal facultativo y deenfermería del servicio de urgencias, así como con las personasencargadas de la coordinación de la emergencia.Las medicaciones que mayoritariamente se utilizaron fueronexpansores plasmáticos, fluidoterapia, productos hemoderivados,analgésicos, antisépticos, miorrelajantes de acción periférica yantibióticos, que coinciden con las utilizadas por otro hospital deMadrid en el mismo suceso.Conclusiones: El servicio de farmacia, como cualquier otrodel hospital, debe estar preparado para afrontar con rapidez y eficaciacualquier situación de emergencia. Disponer de un protocoloque establezca las principales normas de actuación resulta convenientepara disminuir los tiempos de reacción, adelantarse a lasposibles complicaciones y solventar de manera efectiva este tipode situaciones

Objective: To describe the intervention of a pharmacydepartment, as well as medication requirements, in the healthcareemergency situation brought about by the terrorist attack ofMarch 11, 2004 in Madrid. To compare this intervention withother similar experiences reported in the medical literature.Method: A compilation of actions carried out by pharmacistsdirectly involved in the management of this incident. A literaturesearch of Medline, Cochrane Library, and Spanish Index Medicusdatabases.Results: The pharmacy department acted to ensure the availabilityof all medication needed in the management of casualtiesby placing urgent orders in pharmaceutical laboratories, simplifyingdistribution networks, and staying in permanent contact withthe medical and nursing staff of the emergency department, aswell as with people in charge of emergency coordination.Most commonly used medications included plasma expanders,fluid therapy, blood-derived products, pain killers, antiseptics,peripheral myorelaxants, and antibiotics, which are consistentwith those employed by other Madrid hospitals for this sameattack.Conclusions: The pharmacy department, as any otherdepartment in a hospital, should be ready to rapidly and effectivelycope with any emergency situation. Having a protocol availableincluding major intervention guidelines is advisable to reduce reactiontimes, anticipate potential complications, and effectively solvesuch situations

[Influence of antiretroviral therapy characteristics on pediatric patient adherence]. / Influencia de las características del tratamiento antirretroviral en la adherencia del paciente pediátrico.

OBJECTIVE: To analyze difficulties in achieving optimal adherence to antiretroviral therapy as perceived by pediatric patient caregivers in relation to treatment characteristics. METHODS: Design of a subjective numeric scale-based questionnaire, and its administration to caregivers of pediatric patients undergoing active antiretroviral therapy in our hospital, after verbal informed consent for interviewing. The questionnaire aimed to assess on a scale from 0 (no difficulty for adherence) to 5 (maximal difficulty) a number of treatment-related factors: a) number of drugs and dosage regimen; b) organoleptic properties of drugs; c) treatment administration; d) adverse events; and e) antiretroviral therapy effectiveness perceived by caregiver. The questionnaire was proposed to all caregivers, and was performed by a pharmacist in a private space within the pharmacy department. RESULTS: The questionnaire was administered to 28 caregivers of the 32 pediatric patients undergoing active antiretroviral therapy. The following factors were evaluated as entailing moderate difficulties: smell, deglutition, and the immediate gastrointestinal adverse effects of protease inhibitors in liquid dosage form. The only factor evaluated as entailing great difficulty was protease inhibitors flavour in the liquid dosage form. Therapy effectiveness perception was evaluated as high. CONCLUSIONS: According to the overall results from our survey, caregivers evaluated the following factors as entailing moderate to high difficulties for correct adherence: number of drugs in the antiretroviral combination, organoleptic properties (smell, taste) of protease inhibitors (PI), PI-related deglutition problems, and PI-related immediate gastrointestinal adverse events. These factors may be considered potential obstacles for adequate adherence to antiretroviral therapy in pediatric patients.

Efavirenz en dosis única diaria: su influencia en la adherencia al tratamineto antirretroviral / Efavirenz in single daily dose: influence on antiretroviral therapy compliance

El objetivo del estudio es analizar la influencia de efavirenz, en dosis única diaria, en la adherencia al tratamiento antirretroviral y las consecuencias clínicas derivadas de la misma. Para ello se realizó un estudio observacional prospectivo en un total de 52 pacientes a los que se incorporó efavirenz como parte del tratamiento antirretroviral activo. Se analizó la adherencia antes y después del cambio de tratamiento, así como la evolución clínica de los pacientes en función de la respuesta virológica. Los resultados muestran que el 65,3 per cent de los pacientes mejoraron su adherencia y un total de 16 pacientes (30,8 per cent) vieron mejorado el cumplimiento por encima del 95 per cent. Esta mejora de la adherencia se tradujo a nivel clínico en un 85,3 per cent de pacientes que presentaron respuesta virológica (completa o parcial). De forma global, se ha pasado de 9 pacientes (17,3 per cent) con una adherencia > 95 per cent a 20 pacientes (38,5 per cent) con una adherencia > 95 per cent. Los resultados señalan la importancia de la dosis única diaria como factor facilitador de la adherencia al tratamiento antirretroviral y por tanto, con capacidad para incrementar la efectividad clínica del mismo (AU)