Aluminium in parenteral nutrition: a systematic review.

Aluminium (Al) toxicity problem in parenteral nutrition solutions (PNS) is decades old and is still unresolved. The aim of this review is to gather updated information about this matter, regarding legislation, manifestations, diagnostics and treatment, patient population at risk and the actions to be taken to limit its accumulation. A structured search using MeSH vocabulary and Title/Abstract searches was conducted in PubMed (http://www.pubmed.gov) up to November 2012. Al is ubiquitous, facilitating its potential for exposure. Nevertheless, humans have several mechanisms to prevent significant absorption and to aid its elimination; therefore, the vast majority of the population is not at risk for Al toxicity. However, when protective gastrointestinal mechanisms are bypassed (for example, parenteral fluids), renal function is impaired (for example, adult patients with renal compromise and neonates) or exposure is high (for example, long-term PNS), Al is prone to accumulate in the body, including manifestations such as impaired neurological development, Alzheimer's disease, metabolic bone disease, dyslipemia and even genotoxic activity. A high Al content in PNS is largely the result of three parenteral nutrient additives: calcium gluconate, inorganic phosphates and cysteine hydrochloride. Despite the legislative efforts, some factors make difficult to comply with the rule and, therefore, to limit the Al toxicity. Unfortunately, manufacturers have not universally changed their processes to obtain a lower Al content of parenteral drug products (PDP). In addition, the imprecise information provided by PDP labels and the high lot-to-lot variation make the prediction of Al content rather inaccurate.

[Weight monitoring in parenteral nutrition: from theory to practice]. / Control gravimétrico en la nutrición parenteral: de la teoría a la práctica.

OBJECTIVE: To assess the usefulness of establishing a routine gravimetric as quality assurance after the development of parenteral nutrition (PN) with a gravimetric error less than ± 5%. MATERIAL AND METHODS: Prospective study in which 5 to 8 large volume PN were weighed daily during 2 months and for 4 months all small volume PN, considering this the real weight. The theoretical weight was calculated taking into account the densities, volumes of all products used in processing and the weight of the bags used. The gravimetric error was calculated as a percentage compared to the theoretical weight. RESULTS: 168 large volume PN and 42 small volume were weighed, gravimetric errors measures were 1.42% (SD=1.31) and 1.26% (SD=0.64), with a gravimetric error less than 5% in 98,8% and 100% respectively. CONCLUSION: Establishing a routine gravimetric control is an useful strategy that can help to guarantee the quality of the PN development.

Control gravimétrico en la nutrición parenteral: de la teoría a la práctica / Weight monitoring in parenteral nutrition: from theory to practice

Objetivo: Valorar la utilidad de un control gravimétrico rutinario como control de calidad tras la elaboración de nutriciones parenterales (NP) con un error gravimétrico inferior al ± 5%. Material y métodos: Estudio prospectivo, en el que durante 2 meses se pesaron diariamente de 5 a 8 NP de gran volumen y durante 4 meses todas las NP de pequeño volumen, considerándose este valor el peso real. El peso teórico se calculó teniendo en cuenta las densidades, los volúmenes de todos los productos utilizados en la elaboración y el peso de las bolsas multicapas utilizadas. El error gravimétrico se calculó en porcentaje con respecto al peso teórico. Resultados: Se pesaron 168 NP de gran volumen y 42 de pequeño volumen, las medias de los errores gravimétricos fueron 1,42% (SD = 1,31) y 1,26% (SD = 0,64), con un error gravimétrico inferior al 5% en el 98,8% y 100% respectivamente. Conclusión: Establecer un control gravimétrico rutinario es una estrategia útil que puede ayudar a garantizar la calidad de la elaboración de NP (AU)

Objective: To assess the usefulness of establishing a routine gravimetric as quality assurance after the development of parenteral nutrition (PN) with a gravimetric error less than ± 5%. Material and methods: Prospective study in which 5 to 8 large volume PN were weighed daily during 2 months and for 4 months all small volume PN, considering this the real weight. The theoretical weight was calculated taking into account the densities, volumes of all products used in processing and the weight of the bags used. The gravimetric error was calculated as a percentage compared to the theoretical weight. Results: 168 large volume PN and 42 small volume were weighed, gravimetric errors measures were 1,42% (SD = 1,31) and 1,26% (SD = 0,64), with a gravimetric error less than 5% in 98,8% and 100% respectively. Conclusion: Establishing a routine gravimetric control is an useful strategy that can help to guarantee the quality of the PN development (AU)

Elaboración de una relación de nombres de medicamentos similares en los que se recomienda utilizar letras mayúsculas resaltadas / Development of a List of Look-alike Drug Names With Recommended Tall Man Letters

Objetivo Elaborar una relación de nombres de medicamentos similares con letras mayúsculas resaltadas, que facilite y estandarice la implantación de esta técnica en prácticas dirigidas a reducir errores por similitud de nombres. Material y métodos Se realizaron dos encuestas estructuradas. La primera incluyó 46 pares, grupos o nombres de medicamentos similares con letras mayúsculas, procedentes de las listas establecidas por la FDA, ISMP y CAPCA/ISMP-Canadá, y 32 seleccionados de la base de datos del ISMP-España y Consejo de COF. La segunda incluyó 27 pares, grupos o nombres propuestos por los encuestados y 11 procedentes de la actualización del ISMP. Se formularon preguntas sobre la utilidad de la técnica y su implantación en los hospitales. Participaron en la primera encuesta 90 farmacéuticos de diferentes hospitales y 89 en la segunda. Resultados La relación de nombres de medicamentos similares con letras mayúsculas resaltadas elaborada recoge 107 nombres agrupados en 44 pares o grupos. Un 93,3% de los encuestados opinó que esta técnica debería implantarse para denominar a los medicamentos, tanto en el etiquetado de la industria farmacéutica (91,1%) como en otros lugares donde aparecen los nombres, como en las pantallas de prescripción informatizada (90%), de farmacia (82,2%) o de los sistemas automatizados de dispensación (81,1%), en etiquetado de preparaciones y estantes, etc. Solo 9 (10%) de los hospitales utilizaban esta técnica. Conclusiones La disponibilidad de esta relación de nombres similares en los que se recomienda utilizar letras mayúsculas resaltadas podría facilitar su aplicación en prácticas de diferenciación de nombres, actualmente reducida en nuestro país(AU)

Objective To develop a list of look-alike drug names with tall man letters, that will facilitate and standardize the implementation of this technique in safety practices designed to reduce errors caused by look-alike names. Material and methods Two structured surveys were carried out. The first survey included 46 pairs, groups, or individual look-alike drug names with tall man letters from the lists established by the FDA, ISMP and CAPCA/ISMP-Canada, and 32 selected from ISMP-Spain and the COF Council database. The second survey included 27 proposals made by those respondents who completed the first survey and 11 from the ISMP updated list. Participants were asked about the usefulness and current implementation of the technique. Ninety pharmacists from different hospitals participated in the first survey and 89 in the second. Results The list of look-alike drug names with tall man letters which has been developed includes 107 names structured into 44 pairs or groups. Of the respondents, 93.3% felt that this technique should be implemented for identifying medications, not only on pharmaceutical industry labels (91.1%) but also in other places where drug names appear, including computerized prescription screens (90%), pharmacy system screens (82.2%), automated dispensing cabinet screens (81.1%), labels for pharmacy preparations and shelves, etc. Only 9 hospitals (10%) were using this technique. Conclusions The availability of this list of look-alike drug names for which tall man lettering is recommended may encourage the use of this technique for differentiating names in Spain where it is currently not greatly used (AU)

Development of a list of look-alike drug names with recommended tall man letters.

OBJECTIVE: To develop a list of look-alike drug names with tall man letters, which will facilitate and standardize the implementation of this technique in safety practices designed to reduce errors caused by look-alike names. MATERIAL AND METHODS: Two structured surveys were carried out. The first survey included 46 pairs, groups, or individual look-alike drug names with tall man letters from the lists established by the FDA, ISMP and CAPCA/ISMP-Canada, and 32 selected from ISMP-Spain and the COF Council database. The second survey included 27 proposals made by those respondents who completed the first survey and 11 from the ISMP updated list. Participants were asked about the usefulness and current implementation of the technique. Ninety pharmacists from different hospitals participated in the first survey and 89 in the second. RESULTS: The list of look-alike drug names with tall man letters which has been developed includes 107 names structured into 44 pairs or groups. Of the respondents, 93.3% felt that this technique should be implemented for identifying medications, not only on pharmaceutical industry labels (91.1%) but also in other places where drug names appear, such as computerized prescription screens (90%), pharmacy system screens (82.2%), automated dispensing cabinet screens (81.1%), labels for pharmacy preparations and shelves, etc. Only 9 hospitals (10%) were using this technique. CONCLUSIONS: The availability of this list of look-alike drug names for which tall man lettering is recommended may encourage the use of this technique for differentiating names in Spain where it is currently not greatly used.

[Comparison of two formulae for the calculation of glomerular filtration in the dosage of zoledronic acid]. / Comparación de dos fórmulas de cálculo de filtrado glomerular en la dosificación del ácido zoledrónico.

OBJECTIVE: To validate the use of a formula that does not require the patient's weight (Levey formula) for calculating creatinine clearance in the adjustment of the dosage of zoledronic acid. METHOD: Prospective observational study in which zoledronic acid prescriptions in the Oncology and Haematology departments were recorded over the course of 8 months. The adjustment of the dose of zoledronic acid was carried out in accordance with creatinine clearance obtained using two different equations; the Cockcroft-Gault equation which is based on medical records, and the Levey formula which does not require the patient's weight for the calculation. The results of zoledronic acid dosage from both equations were compared using the SPSS statistics programme, via the comparison of the two measurements using the t Student-Fisher (T-test.) RESULTS: The T-Test provided a t-test value of t = 3,366, with 112 degrees of freedom and a degree of bilateral importance of p = 0.001. The difference between both measurements was d = 0.051 +/- 0.162) and the confidence interval was 95 %, 0.082 to 0.021. From the data obtained in the T-Test, the degree of bilateral importance (p = 0.001 < 0.05) indicated that the results of the test were statistically significant. CONCLUSIONS: The difference between the dosages obtained when comparing both methods of glomerular filtration is statistically significant, although not clinically relevant, therefore the MDRD-4 formula (Levey) could be used if the patient's weight is not available.

Comparación de dos fórmulas de cálculo de filtrado glomerular en la dosificación del ácido zoledrónico / Comparison of two formulae for the calculation of glomerular fi ltration in the dosage of zoledronic acid

Objetivo: Validar la utilización de una fórmula que no requiera del peso del paciente (fórmula de Levey) para el cálculo del aclaramiento de creatinina en el ajuste de la dosificación del ácido zoledrónico. Método: Estudio observacional prospectivo en el que se recogen durante un período de 8 meses las prescripciones de ácido zoledrónico realizadas en los servicios de Oncología y Hematología. Se realiza el ajuste de la dosis de ácido zoledrónico de acuerdo con el aclaramiento de creatinina obtenido mediante 2 ecuaciones diferentes: a) la fórmula de Cockcroft-Gault, que es la propuesta en la ficha técnica del medicamento, y b) la fórmula de Levey, que no requiere del peso del paciente para su cálculo. Se comparan los resultados de dosificación de ácido zoledrónico de ambas ecuaciones con el programa estadístico SPSS, mediante la prueba de comparación de 2 medias calculando la t de Student-Fisher (T-test). Resultados: La prueba t proporcionó un valor t = ¿3,366, con 112 grados de libertad y un grado de significación bilateral p = 0,001. La diferencia entre ambas medias ± desviación estándar fue de ¿0,051 ± 0,162, y el intervalo de confianza del 95 %, ¿0,082 a ¿0,021. A partir de los datos obtenidos en la prueba estadística T-test, el grado de significación bilateral p = 0,001 < 0,05 indicó que el resultado de la prueba era estadísticamente significativo. Conclusiones: La diferencia de dosis obtenida al comparar ambos métodos de cálculo del filtrado glomerular es estadísticamente significativa, aunque sin relevancia clínica, con lo que se podría utilizar la fórmula de la Modification of Diet in Renal Disease 4 (Levey), si no disponemos del peso del paciente (AU)

Objective: To validate the use of a formula that does not require the patient’s weight (Levey formula) for calculating creatinine clearance in the adjustment of the dosage of zoledronic acid.Method: Prospective observational study in which zoledronic acid prescriptions in the Oncology and Haematology departments were recorded over the course of 8 months. The adjustment of the dose of zoledronic acid was carried out in accordance with creatinine clearance obtained using two different equations; the Cockcroft-Gault equation which is based on medical records, and the Levey formula which does not require the patient’s weight for the calculation. The results of zoledronic acid dosage from both equations were compared using the SPSS statistics programme, via the comparison of the two measurements using the t Student-Fisher (T-test.)Results: The T-Test provided a t-test value of t = —3,366, with 112 degrees of freedom and a degree of bilateral importance of p = 0.001. The difference between both measurements was d = —0.051 ± 0.162) and the confidence interval was 95 %, —0.082 to —0.021. From the data obtained in the T-Test, the degree of bilateral importance (p = 0.001 < 0.05) indicated that the results of the test were statistically significant. Conclusions: The difference between the dosages obtained when comparing both methods of glomerular filtration is statistically significant, although not clinically relevant, therefore the MDRD-4 formula (Levey) could be used if the patient’s weight is not available (AU)

Evolución de la prescripción de analgésicos opioides en atención primaria, especializada y hospitalaria del Área Sanitaria de Puertollano. 2001-2006 / No disponible

Objetivos: describir la evolución del consumo de analgésicos opioides en el Área Sanitaria de Puertollano en el periodo 2001-2005 y evaluar el mismo tras la puesta en marcha en 2006 de un recurso de Cuidados Paliativos como medida de resultado. Método: análisis de los cinco opioides mayores más prescritos. Los datos de consumo se obtuvieron del archivo informático del Servicio de Farmacia. Se evaluaron las prescripciones realizadas por Atención Primaria, médicos especialistas y en el hospital, expresado en DHD (dosis diaria definida por mil habitantes por día) para los dos primeros niveles y en DDD (dosis diaria definida)/100 estancias para el tercero, entre los años 2001-2006. Resultados: en Atención Primaria se observa un incremento progresivo en el consumo global de opioides, pasando de 0,68 a 2,89 DHD. Por fármacos, destaca la prescripción de opioides de liberación transdérmica, que se incrementa desde 0,51 DHD en 2001 hasta 2,80 DHD en 2006, representando este año el 93% de las DHD totales. Las DHD prescritas por médicos especialistas aumentan de forma más moderada, de 0,02 a 0,06, y en 2006 disminuyen ligeramente. Sólo las de morfina oral se incrementan acusadamente en este último año, pasando de 0,0003 DHD en 2005 a 0,0064 DHD en 2006. También aquí las DHD de fármacos administrados en parches suponen casi la totalidad del grupo(99,2% en 2001), aunque disminuye el porcentaje ligeramente en 2006 (90,2%). En el ámbito hospitalario, no se observa correlación entre las DDD consumidas, ni de manera global ni para cada uno de los fármacos, con el número de estancias hospitalarias. Sin embargo en 2006 existe un incremento importante del consumo global y de morfina en particular (60,8% de las DDD/100 estancias totales), que supera por vez primera al de opioides de liberación transdérmica (31,6%), sin que una variación apreciable del case-mix lo justifique. Conclusiones: se observa un incremento continuado en las DHD prescritas tanto por médicos especialistas como en Atención Primaria. Sin embargo, el consumo en el hospital evoluciona de forma errática. Este comportamiento parece cambiar coincidiendo con el inicio de la actividad del Equipo Hospitalario de Cuidados Paliativos (AU)

Objectives: to describe the trends of use for opioid analgesics in theArea of Puertollano during the period 2001-2005, and to evaluate it as an outcome measure after launching a Palliative Care Program in 2006. Method: an analysis of the five strong opioids most commonly prescribed. Data on use were obtained from the Pharmacy Service computer files. The prescription of opioid analgesics in primary, specialized, and hospital care were assessed and expressed as DHD (Defined Daily Dose per 1,000 inhabitants per day) for the two first sanitary levels, and as DDD (Defined Daily Doses)/100 hospital stays for the third one, from 2001 to 2006. Results: there is a gradual increase in the overall use of opioids that moves from 0.68 to 2.89 DHDs in primary care. The prescription of transdermal release opioids, which increased from 0.51 DHDs in 2001 to 2.80 in 2006, should be highlighted. This represents 93% of total DHDs this year. DHDs prescribed by medical specialists increased in a more moderate way, from 0.02 to 0.06, and decreased slightly in 2006. Only oral morphine DHDs increased sharply in the past year, from 0.0003 DHDs in 2005 to 0.0064 DHDs in 2006. Here, the DHDs for drugs administered in patches account for almost the entire group too (99.2% in 2001), although its share declined slightly in 2006 (90.2%).In the hospital setting no correlation between DDDs used, either overall or for each drug, and number of hospital stays was seen.However, in 2006 there was a significant increase in global consumption, particularly for morphine (60.8% of total DDDs/100 hospital stays), exceeding for the first time those of transdermal release opioids (31.6%) without a significant variation of case-mix warrants. Conclusions: there is continued growth in DHDs prescribed by both specialists and primary care physicians. However, hospital use evolves in an erratic manner. This behavior seems to be changing since palliative care teams were implemented (AU)

Hepatitis colestática aguda secundaria a amoxicilina-ácido clavulánico / Acute cholestatic hepatitis secondary to amoxicillin-clavulanic acid

Tras el tratamiento con la asociación amoxicilina-ácido clavulánico se han comunicado diversos casos de reacciones hepáticas.A continuación se describen dos casos de hepatitis colestásica aguda secundaria a amoxicilina-ácido clavulánico; tras descartar la etiología viral, autoinmune y otras causas de daño hepático. En uno de los casos, la biopsia hepática mostró infiltración inflamatoria portal y colangitis y en el otro mostró colestasis y hepatocitos con esteatosis hepática (AU)