Calcinosis cutánea grave tratada exitosamente con una fórmula magistral tópica W/O de tiosulfato sódico al 10 por ciento / Sever calcinosis cutis successfully treated with a topical W/O-emulsion of sodium thiosulfpercentate 10

La calcinosis cutánea es una enfermedad producida por acumulación y depósito de sales de calcio en los tejidos, que puede dar lugar a importantes lesiones, y cuyo abordaje terapéutico no está claramente establecido: se restringe al tratamiento sintomático o tiosulfato sódico intravenoso en los casos más graves, pero su administración conlleva unos riesgos y se hace especialmente difícil en pacientes pediátricos. Presentamos el caso de un niño de 6 años de edad, diagnosticado de calcinosis cutánea grave secundaria a un tratamiento con gluconato cálcico intravenoso, al que se prescribió una fórmula magistral de tiosulfato sódico tópico al 10%. En el servicio de farmacia del hospital donde se desarrolló el estudio, se llevó a cabo la formulación del tratamiento en forma de emulsión acuosa/oleosa. El paciente experimentó una rápida y progresiva curación con la fórmula magistral prescrita (AU)

Calcinosis cutis is a disease caused by accumulation and deposition of calcium salts in the tissue, which can result in serious injuries, whose therapeutic approach is not clearly established: it is restricted to symptomatic treatment or intravenous sodium thiosulfate in the most severe cases, but its administration carries some risks and is particularly difficult in pediatric patients. We report the case of a 6 year old children diagnosed of severe skin calcinosis secondary to treatment with intravenous calcium gluconate, for who it was prescribed a topical formulation of sodium thiosulfate 10%. In the pharmacy department of the hospital where the study was conducted, the topical formulation was prepared as aqueous/oil emulsion. The patient experienced a successfully, rapid and progressive recovery with the treatment prescribed (AU)

Eficacia de la colonografía por tomografía computarizada frente a la colonoscopia como prueba de cribado del cáncer colorrectal / Efficacy of CT colonography versus colonoscopy in screening for colorectal cancer

Objetivo. Determinar la eficacia y efectividad de la colonografía por tomografía computarizada (CTC) frente a la colonoscopia como pruebas de cribado para el cáncer colorrectal (CCR). Material y métodos. Se realizó una revisión sistemática de la literatura científica que incluyó todos los estudios que evaluaran la eficacia de la CTC como prueba de cribado del CCR. Quedaron excluidos aquellos artículos que analizaran la eficacia de otras técnicas de cribado para el CCR o los que utilizaran la CTC como técnica diagnóstica o en poblaciones sintomáticas. De las 213 referencias obtenidas se seleccionaron 9 estudios tras lectura crítica. Resultados. La especificidad demostrada para la CTC en el cribado del CCR fue alta y disminuía con el diámetro del pólipo a detectar. La sensibilidad para la CTC para detectar pólipos de diámetro igual o menor de 6mm resultó ser muy baja y heterogénea, aunque aumentaba para la detección de pólipos de más de 9mm de diámetro. Conclusión. La CTC demostró tener alta especificidad y una sensibilidad muy heterogénea, aunque en la mayoría de los casos no alcanzó los porcentajes de sensibilidad y especificidad logrados por la colonoscopia (AU)

Objective. To determine the efficacy and effectiveness of CT colonography in comparison with those of colonoscopy in screening for colorectal cancer. Material and methods. We systematically reviewed all the studies in the scientific literature that assessed the efficacy of CT colonography in screening for colorectal cancer. We excluded articles that assessed the efficacy of other screening techniques for colorectal cancer and those that used CT colonography in the diagnostic workup of suspected lesions or symptomatic patients. After a critical reading of the 213 references obtained, we selected nine studies. Results. The specificity of CT colonography in screening for colorectal cancer was high, although it decreased with the diameter of the polyp to be detected. The sensitivity of CT colonography in the detection of polyps less than or equal to 6mm in diameter was very low and heterogeneous, although it was higher for polyps greater than 9mm in diameter. Conclusion. CT colonography has high specificity but very heterogeneous sensitivity, although in most cases it was not as sensitive or specific as conventional colonoscopy (AU)

Consensus method to update the GINF formulary request form

Objective: To update the Guideline for the Introduction of New Drugs in the Formulary (GINF form) using the RAND/UCLA appropriateness method, which combines the best available evidence and an expert panel’s judgement. Study Design/Methods: Two procedures were employed to detect where improvements could be made to the former versions of the request form and to transform them into concrete scenarios, found from a telephone survey with GINF form users, and a structured review of the scientific literature. The list of scenarios was later assessed by an expert panel. In a series of successive rounds, the rest of the research team critically assessed the expert panel’s result, applying a score. Results: A total of 52 improvement proposals were registered; 31 of them dealt with the form structure and the remaining 21 referred to the form process. Six formulary request forms were selected from the literature review. The final version included 24 assessed scenarios mainly addressing clinical trials’ validity, qualitative assessment and local implications of the requested drug. Conclusions: A new version of the GINF form has been developed. Much improvement has been made based on the guide users’ opinion, available evidence and similar experiences that have been carried out internationally. The whole process has been subject to the experts’ opinion following a contrasted, consensus methodology: RAND/UCLA appropriateness method (AU)

Objetivo: Diseñar una nueva versión de la Guía para la Introducción de Nuevos Fármacos (GINF), ˜utilizando para ello la metodología RAND/UCLA sobre el uso adecuado, que combina la mejor evidencia disponible con el juicio de un panel de expertos. Diseño del estudio/métodos: ˜ Se emplearon 2 procedimientos para detectar oportunidades de mejora de las versiones anteriores de la guía, que fueron transformadas en escenarios concretos: una encuesta telefónica a usuarios de la GINF, y una revisión estructurada de la literatura científica. Esta lista de escenarios fue evaluada por un panel de expertos mediante rondas sucesivas. El resto del equipo de investigación evaluó críticamente el resultado del panel de expertos. Resultados: Se registraron 52 propuestas de mejora, 31 de ellas se refieren a la estructura de la guía y las 21 restantes se refieren al procedimiento de utilización de la guía. En cuanto a la búsqueda bibliográfica, 6 de las guías de inclusión de nuevos medicamentos fueron seleccionadas. La versión final incluyó 24 de los escenarios propuestos orientados principalmente a la validez del ensayo clínico, la evaluación cualitativa y las consecuencias locales del fármaco solicitado. Conclusiones: La nueva versión de la guía GINF llevada a cabo incluye muchas mejoras extraídas tanto de la opinión de los usuarios de guía como de la mejor evidencia disponible y las experiencias similares que se han llevado a cabo a nivel internacional. Todo el proceso ha sido sometido a la opinión de los expertos tal como indica la metodología de consenso RAND/UCLA (AU)

La vitamina K como profilaxis para la enfermedad hemorrágica del recién nacido / Prophylactic Vitamin K for Vitamin K Deficiency Bleeding of the Newborn

Objetivo La administración de vitamina K inmediatamente después del nacimiento ha demostrado un descenso significativo de la incidencia de hemorragias neonatales, pero no existe evidencia suficiente que determine la forma de administración más adecuada. El objetivo de esta revisión es determinar la eficacia de la vitamina K administrada por vía oral frente a la vía intramuscular en la prevención de la enfermedad hemorrágica del recién nacido. Métodos Se realizó una revisión sistematizada de las principales bases de datos (Medline, Embase y Cochrane), entre otras sin limitación por fecha, idioma ni tipo de estudio. Los estudios seleccionados evaluaban la eficacia de la vitamina K. Se excluyeron aquellos estudios realizados en embarazadas, niños pretérmino o en pacientes afectos de alguna enfermedad. La validez de estos estudios fue evaluada mediante herramientas CASPe para revisiones sistemáticas y ensayos clínicos. Resultados Los estudios incluidos fueron cuatro ensayos clínicos y una revisión sistemática. Únicamente dos estudios evaluaron aspectos clínicos en los cuales se observó un descenso en la incidencia de hemorragias en el recién nacido tras la profilaxis con vitamina K por vía intramuscular. Con respecto a la vía oral, diferentes estudios analizaron la eficacia de la vitamina K mediante la determinación de parámetros bioquímicos (factor X, índice y tiempo de protrombina, vitamina K1 en plasma y antígeno de protrombina, entre otros) con resultados poco concluyentes en cuanto a la vía de administración y al número de dosis. Conclusiones(..)(AU)

Background The administration of vitamin K immediately after birth has shown a significant decrease in the incidence of newborn bleeding, but there is not enough evidence to determine the most appropriate method of administration. The objective of this review is to determine the effectiveness of orally administered vitamin K compared to the intramuscular route in the prevention of haemorrhagic disease of newborn (HDN).Methods We conducted a systematic review of the main databases (Medline, Embase and Cochrane, among others) without limitation by date, language or type of study. Selected studies evaluated the efficacy and safety of vitamin K. Excluded were studies in pregnant women in preterm infants or patients with pathology. The validity of these studies was assessed by CASPe tools for systematic reviews and clinical trials. Results Only two studies evaluated clinical aspects. They showed a reduction in the incidence of bleeding in the newborn after intramuscular prophylaxis with vitamin K. With regard to the oral route, different studies examined the effectiveness of vitamin K by determining biochemical parameters (factor X, prothrombin time and index, vitamin K1 in plasma and prothrombin antigen, among others) with inconclusive results regarding the route of administration and the number of doses. Conclusions There is sufficient evidence to support the effectiveness of a single intramuscular dose of vitamin K to prevent the classic form of HDN. With regard to late HDN and oral route, the results are inconclusive because the studies used biochemical indicators of effectiveness, which cannot be correlated with the actual coagulation status of the newborn due to lack of scientific evidence(AU)

[Efficacy of CT colonography versus colonoscopy in screening for colorectal cancer]. / Eficacia de la colonografía por tomografía computarizada frente a la colonoscopia como prueba de cribado del cáncer colorrectal.

OBJECTIVE: To determine the efficacy and effectiveness of CT colonography in comparison with those of colonoscopy in screening for colorectal cancer. MATERIAL AND METHODS: We systematically reviewed all the studies in the scientific literature that assessed the efficacy of CT colonography in screening for colorectal cancer. We excluded articles that assessed the efficacy of other screening techniques for colorectal cancer and those that used CT colonography in the diagnostic workup of suspected lesions or symptomatic patients. After a critical reading of the 213 references obtained, we selected nine studies. RESULTS: The specificity of CT colonography in screening for colorectal cancer was high, although it decreased with the diameter of the polyp to be detected. The sensitivity of CT colonography in the detection of polyps less than or equal to 6mm in diameter was very low and heterogeneous, although it was higher for polyps greater than 9mm in diameter. CONCLUSION: CT colonography has high specificity but very heterogeneous sensitivity, although in most cases it was not as sensitive or specific as conventional colonoscopy.

Consensus method to update the GINF formulary request form.

OBJECTIVE: To update the Guideline for the Introduction of New Drugs in the Formulary (GINF form) using the RAND/UCLA appropriateness method, which combines the best available evidence and an expert panel's judgement. STUDY DESIGN/METHODS: Two procedures were employed to detect where improvements could be made to the former versions of the request form and to transform them into concrete scenarios, found from a telephone survey with GINF form users, and a structured review of the scientific literature. The list of scenarios was later assessed by an expert panel. In a series of successive rounds, the rest of the research team critically assessed the expert panel's result, applying a score. RESULTS: A total of 52 improvement proposals were registered; 31 of them dealt with the form structure and the remaining 21 referred to the form process. Six formulary request forms were selected from the literature review. The final version included 24 assessed scenarios mainly addressing clinical trials' validity, qualitative assessment and local implications of the requested drug. CONCLUSIONS: A new version of the GINF form has been developed. Much improvement has been made based on the guide users' opinion, available evidence and similar experiences that have been carried out internationally. The whole process has been subject to the experts' opinion following a contrasted, consensus methodology: RAND/UCLA appropriateness method.

[Prophylactic vitamin K for vitamin K deficiency bleeding of the newborn]. / La vitamina K como profilaxis para la enfermedad hemorrágica del recién nacido.

BACKGROUND: The administration of vitamin K immediately after birth has shown a significant decrease in the incidence of newborn bleeding, but there is not enough evidence to determine the most appropriate method of administration. The objective of this review is to determine the effectiveness of orally administered vitamin K compared to the intramuscular route in the prevention of hemorrhagic disease of newborn (HDN). METHODS: We conducted a systematic review of the main databases (Medline, Embase and Cochrane, among others) without limitation by date, language or type of study. Selected studies evaluated the efficacy and safety of vitamin K. Excluded were studies in pregnant women in preterm infants or patients with pathology. The validity of these studies was assessed by CASPe tools for systematic reviews and clinical trials. RESULTS: Only two studies evaluated clinical aspects. They showed a reduction in the incidence of bleeding in the newborn after intramuscular prophylaxis with vitamin K. With regard to the oral route, different studies examined the effectiveness of vitamin K by determining biochemical parameters (factor X, prothrombin time and index, vitamin K1 in plasma and prothrombin antigen, among others) with inconclusive results regarding the route of administration and the number of doses. CONCLUSIONS: There is sufficient evidence to support the effectiveness of a single intramuscular dose of vitamin K to prevent the classic form of HDN. With regard to late HDN and oral route, the results are inconclusive because the studies used biochemical indicators of effectiveness, which can not be correlated with the actual coagulation status of the newborn due to lack of scientific evidence.

[Implementation of the guidelines for the introduction of new drugs (GINF) in Andalusian hospitals]. / Implantación de la guía para la incorporación de nuevos fármacos (GINF) en los hospitales andaluces.

OBJECTIVE: To measure the level of implementation of the GINF (guidelines for the introduction of new drugs) in Andalusian hospitals, describe the characteristics of this implementation and analyse if any of the hospital s dependent variables could influence these characteristics. METHOD: A telephone survey was carried out in the hospitals included in the Department of Health list. The survey consisted of 11 closed questions on different variables in the hospital and the GINF use profile, and an open question about the improvements carried out and proposals for improvement. The results were analysed according to the type of hospital (category, training, geographical location) in order to detect possible differences. RESULTS: A target population of 31 hospitals was identified. The survey was carried out in 29 of these; the level of implementation was 96.5% in the responding hospitals. 23 hospitals used the GINF for 100% of drugs, 6 had carried out local modifications and 80% made proposals for improvement. Significant differences were found in the implementation of the GINF according to resident/intern pharmacist training (p = 0.049), the geographical location (p = 0.004) and the hospital category (p < 0.001). CONCLUSIONS: The GINF have been implemented in almost all public Andalusian hospitals as the guidelines for requesting new drugs. Very few local modifications have been carried out to the guidelines, although numerous proposals for improvement have been made. Differences in use have been identified (No. of drugs, different versions) according to the hospital characteristics (location, training and complexity classification). They are considered a useful tool and influence the drug selection process, in particular in training hospitals with a higher classification.

Implantación de la guía para la incorporación de nuevos fármacos (GINF) en los hospitales andaluces / No disponible

Objetivo: Medir el grado de implantación de la guía GINF enlos hospitales andaluces, describir las características de dichaimplantación y analizar si algunas variables dependientes del hospitalpudieran influir en las mismas.Método: Se realizó una encuesta telefónica a los hospitalesincluidos en catálogo de la Consejería de Salud. La encuesta constabade 11 cuestiones cerradas sobre diferentes variables del hospitaly del perfil de utilización de la GINF, y una cuestión abiertaque recogía mejoras realizadas y propuestas de mejora. Se analizaronlos resultados en función del tipo de hospital (categoría, docencia,localización geográfica) para detectar posibles diferencias.Resultados: Se identificó una población diana de 31 hospitales.La encuesta pudo realizarse en 29; el grado de implantaciónfue del 96,5% en los hospitales respondedores. Veintitrés hospitalesutilizaban la GINF para el 100% de los fármacos, seis habíanrealizado modificaciones locales pero el 80% realizó propuestasde mejora. Se encontraron diferencias significativas en la implantaciónde la GINF en función de la docencia FIR (p = 0,049), lalocalización geográfica (p = 0,004) y la categoría de los hospitales(p < 0,001).Conclusiones: La guía GINF ha sido implantada en la prácticatotalidad de los hospitales públicos andaluces para la solicitudde nuevos fármacos. La guía apenas ha sido modificada localmente,aunque se recogen numerosas propuestas de mejora. Se identificandiferencias en su utilización (número de fármacos, diferentesversiones) en función de las características del hospital (localización,docencia y complejidad). Es considerada una herramientaútil e influyente en el proceso de selección de medicamentos,sobre todo en los hospitales docentes de mayor complejidad

Objective: To measure the level of implementation of theGINF (guidelines for the introduction of new drugs) in Andalusianhospitals, describe the characteristics of this implementation andanalyse if any of the hospital’s dependent variables could influencethese characteristics.Method: A telephone survey was carried out in the hospitalsincluded in the Department of Health list. The survey consisted of11 closed questions on different variables in the hospital and theGINF use profile, and an open question about the improvementscarried out and proposals for improvement. The results wereanalysed according to the type of hospital (category, training, geographicallocation) in order to detect possible differences.Results: A target population of 31 hospitals was identified.The survey was carried out in 29 of these; the level of implementationwas 96.5% in the responding hospitals. 23 hospitals usedthe GINF for 100% of drugs, 6 had carried out local modificationsand 80% made proposals for improvement. Significant differenceswere found in the implementation of the GINF according toresident/intern pharmacist training (p = 0.049), the geographicallocation (p = 0.004) and the hospital category (p < 0.001).Conclusions: The GINF have been implemented in almost allpublic Andalusian hospitals as the guidelines for requesting newdrugs. Very few local modifications have been carried out to theguidelines, although numerous proposals for improvement havebeen made. Differences in use have been identified (No. of drugs,different versions) according to the hospital characteristics (location,training and complexity classification). They are considered auseful tool and influence the drug selection process, in particularin training hospitals with a higher classification

Similitud en la cumplimentación de las guías para la incorporación de nuevos fármacos (GINF) / No disponible

No disponible