[Pharmaceutical intervention with parenteral nutrition]. / Intervención farmacéutica en el ámbito de la nutrición parenteral.

OBJECTIVE: Description and analysis of pharmaceutical interventions for patients with parenteral nutrition and an assessment of the degree of acceptance. METHOD: Prospective six-month study. Design of a data collection sheet (with personal data, the indication for parenteral nutrition, hospital area, nutrition type, time and type of intervention, type of notification, acceptance) for recording interventions carried out based on normal activities: complete review of pharmacotherapy and clinical history. RESULTS: A total of 265 interventions were carried out during the study period (1.5 interventions/day) with a mean of 2.1 interventions/patient. The overall degree of acceptance was 83.77%; significant differences were found between type of communication for the intervention (oral and/or written) and the degree of acceptance. CONCLUSIONS: Adding a pharmacist to the care team permits direct intervention in partnership with the doctor, and it is an effective method for preventing and resolving the complications, generally metabolic, that are associated with parenteral nutrition. Using this process for resolving medication-related problems in hospitalised patients, principally in surgical areas, is an addition to the pharmacist's activities in the area of nutritional support.

[The impact of different renal function measuring methods on the dosages of meropenem, piperacillin/tazobactam and cefepime in critically ill patients]. / Impacto de distintos métodos de estimación de la función renal en la dosificación de meropenem, piperacilina/tazobactam y cefepima en pacientes críticos.

OBJECTIVE: Assesment of dosage deviations of three ss-lactam antibiotics eliminated through the kidneys (meropenem, piperacillin/tazobactam and cefepime) by comparison of two prediction formulae, Cockroft-Gault (CG) and Modification of Diet in Renal Disease (MDRD) with 24 h urinary creatinine clearance (CrCl(24h)), as a reference method. METHOD: 125 samples of 61 critically ill patients (each one with CG, MDRD y CrCl(24h) values) were classified in one of the five stages of the National Kidney Foundation (NKF) according to CrCl(24h). Dosage discrepancies for each antibiotic based on CG y MDRD were studied in reference to CrCl(24h) by percentage agreement and weighted kappa. At each of the NKF stages, daily dosage differences (Delta=DosisCG-DosisCrCl(24h); Delta=DosisMDRD-DosisCrCl(24h)) and percentage of samples with dosage discrepancies by CG and MDRD in reference to CrCl(24h) were calculated. RESULTS: There were no statistically significant differences between the two prediction formulae in respect to CrCl(24h), achieving good degrees of concordance. Deviation percentages fluctuated between 15.2% and 28% and occurred mainly by underdosing on stages 1 and 2 and by overdosing on stages 4 and 5. CONCLUSIONS: The two renal function prediction formulae can be indistinctly used to optimize the ss-lactam antibiotics dose regimen, CG being the easiest one.

[Description of the ISO 9001/2000 certification process in the parenteral nutrition area]. / Descripción del proceso de certificación ISO 9001/2000 en el área de nutrición parenteral.

OBJECTIVE: In order to guarantee quality and safety and to increase user satisfaction, healthcare organisations have integrated quality management systems into their structures. This study describes the process for introducing the UNE-EN-ISO-9001/2000 standard in the parenteral nutrition area. METHOD: A multidisciplinary group established the scope of the standard, focusing on transcription, preparation, dispensation and microbiological control. RESULTS: A detailed procedure describing the sequences of circuits and associated activities, the responsible staff and the action guidelines to be followed was established. Quality and activity markers were also established. CONCLUSIONS: This process has enabled a standard system to be implemented, with its operation perfectly described and documented, allowing its stages to be traceable and supervised. As there is no record of the data obtained beforehand, no direct comparison can be made; its evolution must therefore be analysed in the future.

[Desensitization to cotrimoxazole, rifampicin and penicillin G in nine patients with prior hypersensitivity]. / Original Breve Desensibilización de cotrimoxazol, rifampicina y penicilina G en nueve pacientes con hipersensibilidad previa.

OBJECTIVE: To present a protocol for the administration and development technique of the desensitization regimens for cotrimoxazole, rifampicin and penicillin G hypersensibility. METHOD: A review of the available desensitization protocols for these antibiotics and a retrospective study of desensitization processes undertaken in the center from 1998. A development technique of the antibiotic dosages was designed. RESULTS: Desensitization regimens for cotrimoxazole, rifampicin and penicillin G undertaken in the center in 9 patients came from a protocol by Glucksteins et al., Holland et al. and Wendal et al., respectively. After the literature review and the satisfactory results that allowed subsequent antibiotic administration in the 9 cases, these regimens were established as protocols of the center. CONCLUSIONS: Dosage development and patient administration have a practical application and can help to decrease the potential mistakes related to the complexity of the process.

[Drotrecogin alfa (activated): specific treatment for serious sepsis]. / Drotrecogina alfa (activada): tratamiento específico para la sepsis grave.

Severe sepsis is a high prevalent disease at Intensive Care Units with no specific treatment till recently. Several clinical trials show low serum levels of activated protein C in this kind of patients. Recently, drotrecogin alfa (activated), a recombinant human activated protein C, has been approved in Spain for severe sepsis treatment in addition to the best patient care. Protein C (activated) has antithrombotic, profibrinolitic an antiinflamatory properties. So far, Prowess (phase 3 trial) is the most important clinical trial conducted with drotrecogin alfa (activated) at the moment. It demonstrates not only its efficacy and safety, but also a 19.4% reduction in the relative risk of death. Nevertheless, it is difficult to decide which patients would be candidate for this new therapy due to its lack of experience, high cost and the risk-benefit relationship. This review attempts to provide an overview about this new hospital drug.

[Drug treatment in surgical patients with electrolyte imbalances]. / Intervención farmacéutica en pacientes quirúrgicos con alteraciones electrolíticas.

OBJECTIVE: To qualitatively and quantitatively determine electrolyte imbalances (potassium, phosphorus, magnesium and calcium) in patients admitted for general and gastrointestinal surgery, the degree of these imbalances in percentage detected by medical staff, and the acceptance of the recommendations made by the Hospital Pharmacy Department. METHOD: Seven-month prospective study. Any alteration detected was recorded on a data collection form (personal data, hospital ward, type of alteration, detection by medical staff, type of pharmaceutical intervention, form of notification, acceptance of the intervention, date of imbalance correction, patient receiving parenteral nutrition). RESULTS: 100 imbalances were detected in 66 patients (231 analytical tests revised). A total of 78 interventions were carried out. Most changes were due to hypokalaemia and hypomagnesaemia, hypophosphataemia being the most frequent abnormality in patients receiving parenteral nutrition.The acceptance of pharmaceutical intervention was higher if the information was oral (100% vs. 35% written). Twice the number of analytical tests were performed after interventions (RR: 2.1, 95% CI: 1.11 to 3.94, P=.006). When pharmaceutical intervention was accepted there was a greater number of imbalance resolutions in comparison with those cases which did not accept (RR: 1.5, 95% CI: 1.01 to 2.24, P=.04). CONCLUSIONS: This study shows that electrolyte imbalances are common in surgical patients and the level of detection and monitoring by medical staff is low. Therefore, the pharmacist could help in improving this aspect.

[1.6% peppermint oil solution as intestinal spasmolytic in retrograde endoscopic cholangiopancreatography]. / Esencia de menta al 1,6% como espasmolítico intestinal en la colangiopancreatografía retrógrada endoscópica.

OBJECTIVES: Intestinal peristalsis can impede explorations and interventions using retrograde endoscopic cholangiopancreatography. Systemic spasmolytics are frequently employed to reduce this phenomenon, in spite of the adverse anti-cholinergic effects they are associated with. We proposed a formula using 1.6% peppermint oil solution with local use in order to avoid these adverse side effects. METHOD: We formulated a preparation of 1.6% peppermint oil solution in accordance with the medical literature. The effectiveness of the formula was evaluated in a semi-qualitative manner according to the reduction in peristalsis. RESULTS: We tested two different emulgents, and polysorbate provided the best results. The pilot study carried out with 8 patients demonstrated its effectiveness and safety in reducing intestinal peristalsis. CONCLUSIONS: 1.6% peppermint oil solution constitutes an effective and safe alternative to the use of systemic spasmolytics. More studies are needed with a larger sample size in order to establish its usefulness in normal clinical practice.

[Do physicians know the cost of the treatments and tests they prescribe?]. / Conocen los médicos el coste de los tratamientos y pruebas que solicitan?

OBJECTIVE: To determine the degree of knowledge among physicians regarding the cost of diagnostic tests and commonly used drugs. INDIVIDUALS AND METHODS: An interview was obtained with a representative sample of 164 physicians from a total of 338 (accuracy +/- 3.55), distributed in interns/residents (n:119) and staff members (n:45) from the divisions of Surgery (n:81) and Medicine (n:83) at Hospital Clinic i Provincial, Barcelona. The questionnaire included 15 questions, 10 regarding drugs and 5 diagnostic tests, with 5 possible answers. An arbitrary scoring system was used (correct answer: 5 points; approximate; 3 points; mistake: 1 point) and the percentage of right answers (correct and approximate answers) was also evaluated versus mistakes. The Student "t" test, the analysis of variance and the chi 2 test were used to compare the results. RESULTS: The overall score reached was 2.72 +/- 0.41. Differences between residents vs staff and medicine vs surgery were not significant. The score in questions regarding diagnostic tests was significantly higher than that obtained for drug cost among all group. The percentages of right answers (correct and approximate answers) were 58.8%-61.7% (drugs) and 58.3-60.8% (tests), with no differences among groups. Differences regarding year of residence were also not significant. CONCLUSIONS: The knowledge degree on costs of some drugs and diagnostic tests among physicians is deficient. It is necessary to find standards that contribute to increase the level of information regarding costs derived from the health care delivery process among health care professionals.

Respuesta de los autores: Los acontecimientos adversos a medicamentos originados en el servicio de urgencias y el estudio EVADUR / No disponible

No disponible

Evaluación de los acontecimientos adversos a medicamentos originados en el servicio de urgencias / Evaluation of adverse drug reactions in emergency department practice

OBJETIVO: Determinar la incidencia y caracterizar los acontecimientos adversos a medicamentos (AAM) originados en el servicio de urgencias (SU) de un hospital de tercer nivel. Identificar factores de riesgo asociados a la ocurrencia de AAM y evaluar los errores de medicación (EM) implicados en la aparición de los AAM prevenibles. MÉTODO: Estudio observacional descriptivo de revisión de historias clínicas. Durante 3 meses se seleccionaron pacientes atendidos en el SU que finalmente ingresaron en el centro. La identificación de los AAM se realizó siguiendo una metodología previamente establecida basada en la utilización de señales alertantes (triggers). Se utilizaron los algoritmos de Karch-Lasagna y Hallas para evaluar la causalidad y el cuestionario de Schumock-Thornton para la evitabilidad de los AAM. Todos los posibles AAM fueron validados por dos revisores. RESULTADOS: Se detectaron 31 AAM en los 237 pacientes incluidos, que representan una incidencia del 13%. La mayoría de los AAM presentó una relación de causalidad posible o probable (61% y 29%). El 45% de los AAM fue debido a errores de medicación (EM), que podrían haber sido evitados. Entre los AAM evitables, la principal manifestación fue la alteración de la glucemia atribuida al grupo de antidiabéticos. El principal error implicado fue la falta de prescripción de un medicamento necesario (50%) o la omisión en su administración (21%). En el caso de los AAM inevitables, las principales manifestaciones fueron taquicardia e hiperglicemia asociadas a salbutamol y corticoides respectivamente. Los únicos factores asociados a una mayor prevalencia de AAM fueron el número de fármacos administrados en el SU y la atención en el área de mayor gravedad del SU. CONCLUSIONES: La incidencia de AAM durante la estancia en el SU es elevada y potencialmente prevenible. Estos resultados coinciden con la incidencia descrita en el ámbito hospitalario

OBJECTIVE: To assess the incidence of adverse drug reactions (ADRs) in the emergency department of a tertiary care hospital, to determine the characteristics of the ADRs, to identify related risk factors, and to evaluate medication errors associated with preventable ADRs. METHODS: Descriptive observational study based on data extracted from medical records. Patients admitted to hospital after attendance in the emergency department over a 3-month period were included. ADRs were found following a previously established method to identify ADR clues, or triggers, in patient records. The Karch-Lasagna scale and the Hallas algorithm were used to evaluate causality, and the Schumock-Thornton questionnaire was used to assess ADR preventability. All events that were candidates for classification as ADRs were validated by 2 data collectors. RESULTS: In the records for the 237 patients included, 31 ADRs were detected (incidence, 13%). Most of the ADRs could be assigned a possible (61%) or probable (29%) cause. Forty-five percent of the ADRs were caused by medication errors and could have been prevented. The most common preventable ADRs were hypo- or hyperglycemia related to antidiabetic medication. The most common errors involved failure to prescribe a necessary medication (50%) or failure to administer one (21%). The most common unavoidable ADRs were tachycardia and hyperglycemia related to salbutamol and corticosteroids, respectively. The only factors associated with a higher prevalence of ADRs were the number of drugs administered in the emergency department and admission to the acute-care section of the department. CONCLUSIONS: The incidence of ADRs in this study was high and preventable events were detected. These findings are consistent with evaluations of ADRs in the hospital setting)

Esencia de menta al 1, 6% como espasmolítico intestinalen la colangiopancreatografía retrógrada endoscópica / 1.6% Peppermint oil solution as intestinal spasmolytic in retrograde endoscopic cholangiopancreatography

Objetivos: La aparición de peristaltismo intestinal puede dificultar la realización de exploraciones o intervenciones mediante colangiopancreatografía retrógrada endoscópica(CPRE). Con el fin de disminuirlo es frecuente la utilización de espasmolíticos sistémicos, pese a los efectos adversos anticolinérgicos que presentan. Se propuso formular una preparación de esencia de menta al 1,6% de uso local para evitar estos efectos adversos. Método: Se formuló la preparación de la esencia de menta al 1,6% según la bibliografía encontrada. La efectividad de la fórmula fue valorada de manera semicualitativa según la disminución del peristaltismo. Resultados: Se ensayaron 2 emulgentes siendo polisorbato el más adecuado. El estudio piloto llevado a cabo en 8 pacientes demostró su efectividad y seguridad en la disminución del peristaltismo intestinal. Conclusiones: La esencia de menta al 1,6% constituye una alternativa efectiva y segura a la utilización de espasmolíticos sistémicos. Se requieren posteriores estudios incluyendo un mayor número de pacientes para establecer su utilidad en la práctica clínica habitual (AU)

Objectives: Intestinal peristalsis can impede explorations and interventions using retrograde endoscopic cholangiopancreatography. Systemic spasmolytics are frequently employed to reduce this phenomenon, in spite of the adverse anti-cholinergic effects they are associated with. We proposed a formula using 1.6% peppermint oil solution with local use in order to avoid these adverse side effects. Method: We formulated a preparation of 1.6% peppermint oil solution in accordance with the medical literature. The effectiveness of the formula was evaluated in a semi-qualitative manneraccording to the reduction in peristalsis. Results: We tested two different emulgents, and polysorbate provided the best results. The pilot study carried out with 8 patients demonstrated its effectiveness and safety in reducing intestinal peristalsis. Conclusions: 1.6% peppermint oil solution constitutes an effective and safe alternative to the use of systemic spasmolytics. More studies are needed with a larger sample size in order to establish its usefulness in normal clinical practice (AU)

Intervención farmacéutica en pacientes quirúrgicos con alteraciones electrolíticas / Drug treatment in surgical patients with electrolyte imbalances

Objetivo Determinar cuali y cuantitativamente las alteraciones electrolíticas (relacionadas con potasio, fósforo, magnesio y calcio) en pacientes ingresados en áreas de cirugía general y gastrointestinal, el porcentaje de dichas alteraciones detectado por el equipo médico y el grado de aceptación de las recomendaciones realizadas desde el Servicio de Farmacia Hospitalaria. Método Estudio prospectivo de 7 meses. Toda alteración detectada se registró en una hoja de recogida de datos (datos personales, sala de hospitalización, tipo de alteración, detección por equipo médico, tipo de intervención farmacéutica, modo de notificación, aceptación de la intervención, fecha de corrección de la alteración, paciente en tratamiento con nutrición parenteral).Resultados Se detectaron 100 alteraciones en 66 pacientes (231 analíticas revisadas). Se realizaron un total de 78 intervenciones. La mayoría de alteraciones se debieron a hipokalemias e hipomagnesemias, siendo la hipofosfatemia la alteración más frecuente en pacientes portadores de nutrición parenteral. El grado de aceptación de la intervención farmacéutica por parte del equipo médico fue superior cuando la información fue oral (100 vs 35% escrita). Se consiguió el doble de analíticas de comprobación tras las intervenciones (RR 2,1; IC 95% 1,11-3,94, p=0,006). La aceptación de la intervención comportó una mayor proporción de resoluciones de la alteración respecto a los casos en los que no se aceptó (RR 1,5; IC 95% 1,01-2,24, p=0,04).Conclusiones Este estudio pone de manifiesto que las alteraciones electrolíticas en pacientes quirúrgicos son frecuentes y su grado de detección y seguimiento por parte del equipo médico es bajo. Por ello, el farmacéutico podría contribuir en la mejora de dichos aspectos participando en la atención a estos pacientes (AU)

Objective To qualitatively and quantitatively determine electrolyte imbalances (potassium, phosphorus, magnesium and calcium) in patients admitted for general and gastrointestinal surgery, the degree of these imbalances in percentage detected by medical staff, and the acceptance of the recommendations made by the Hospital Pharmacy Department. Method Seven-month prospective study. Any alteration detected was recorded on a data collection form (personal data, hospital ward, type of alteration, detection by medical staff, type of pharmaceutical intervention, form of notification, acceptance of the intervention, date of imbalance correction, patient receiving parenteral nutrition).Results100 imbalances were detected in 66 patients (231 analytical tests revised). A total of 78 interventions were carried out. Most changes were due to hypokalaemia and hypomagnesaemia, hypophosphataemia being the most frequent abnormality in patients receiving parenteral nutrition. The acceptance of pharmaceutical intervention was higher if the information was oral (100% vs. 35% written). Twice the number of analytical tests were performed after interventions (RR: 2.1, 95% CI: 1.11 to 3.94, P=.006). When pharmaceutical intervention was accepted there was a greater number of imbalance resolutions in comparison with those cases which did not accept (RR: 1.5, 95% CI: 1.01 to 2.24, P=.04).Conclusions This study shows that electrolyte imbalances are common in surgical patients and the level of detection and monitoring by medical staff is low. Therefore, the pharmacist could help in improving this aspect (AU)

Intervención farmacéutica en el ámbito de la nutrición parenteral / Pharmaceutical intervention with parenteral nutrition

Objetivo Descripción y análisis de las intervenciones farmacéuticas realizadas en el ámbito de la nutrición parenteral (NP) y valoración del grado de aceptación. Método Estudio prospectivo de 6 meses. Se diseñó una hoja de recogida de datos (datos personales, indicación de NP, sala de hospitalización, tipo de nutrición, momento y tipo de intervención, modo de notificación y aceptación) en la que se registraron las intervenciones realizadas a partir de la actividad diaria: revisión completa de la farmacoterapia y de la historia clínica. Resultados Se realizaron un total de 265 intervenciones en el período de estudio (1,5 intervenciones/día) con una media de 2,1 intervenciones/paciente. El grado global de aceptación fue del 83,77%, fueron significativas las diferencias encontradas entre el tipo de comunicación de la intervención (oral y/o escrita) y el grado de aceptación. Conclusiones La integración del farmacéutico en el equipo asistencial permite una intervención directa con el médico, y es un método eficaz para la prevención y resolución de complicaciones asociadas a la NP, principalmente de tipo metabólico. Utilizar este proceso para resolver problemas relacionados con la medicación en los pacientes ingresados, principalmente en salas quirúrgicas, proporciona una calidad añadida a la actividad del farmacéutico en el área del soporte nutricional (AU)

Objective Description and analysis of pharmaceutical interventions for patients with parenteral nutrition and an assessment of the degree of acceptance. Method Prospective six-month study. Design of a data collection sheet (with personal data, the indication for parenteral nutrition, hospital area, nutrition type, time and type of intervention, type of notification, acceptance) for recording interventions carried out based on normal activities: complete review of pharmacotherapy and clinical history. Results A total of 265 interventions were carried out during the study period (1.5 interventions/day) with a mean of 2.1 interventions/patient. The overall degree of acceptance was 83.77%; significant differences were found between type of communication for the intervention (oral and/or written) and the degree of acceptance (AU)

Impacto de distintos métodos de estimación de la función renal en la dosificación de meropenem, piperacilina/tazobactam y cefepima en pacientes críticos / No disponible

Objetivo: Evaluar las desviaciones de dosificación de 3 antibióticos betalactámicos eliminados por vía renal (meropenem, piperacili na/tazobactam y cefepima) mediante la comparación de 2 fórmulas de predicción de función renal, Cockroft-Gault (CG) y Modification of Diet in Renal Disease (MDRD), con el aclaramiento de creatinina en orina de 24h (ClCr24h) como método de referencia. Método: Las 125 muestras de 61 pacientes (cada una con sus valores de CG, MDRD y ClCr24h) de una unidad de cuidados intensivos (UCI) se clasificaron en los 5 estadios definidos por la National Kidney Foundation (NKF) en función del ClCr24h. Se estudiaron las discrepancias de dosificación de cada antibiótico según CG o MDRD en referencia al ClCr24h por acuerdo porcentual e índice kappa ponderado. En cada estadio de NKF se cuantificaron las diferencias de dosificación diaria (¿ = DosisCG-DosisClCr24h; ¿ = Dosis MDRD DosisClCr24h) y el porcentaje de muestras con discrepancias de dosificación por CG y MDRD en referencia al ClCr24h. Resultados: En ningún caso se observaron diferencias estadísticamente significativas entre ambas fórmulas con respecto al ClCr24h, obteniendo grados de concordancia buenos. Los porcentajes de desviaciones oscilaron del 15,2% al 28% y ocurrieron mayoritariamente por infradosificación en los estadios 1 y 2, y por sobredosificación en los estadios 4 y 5. Conclusiones: Las dos predicciones de función renal en pacientes de la UCI pueden ser empleadas indistintamente para la dosificación de betalactámicos, aunque la de CG es la más sencilla (AU)

The impact of different renal function measuring methods on the dosages of meropenem, piperacillin/tazobactam and cefepime in critically ill patients Objective: Assesment of dosage deviations of three â-lactam antibiotics eliminated through the kidneys (meropenem, piperacillin/tazobactam and cefepime) by comparison of two prediction formulae, Cockroft-Gault (CG) and Modification of Diet in Renal Disease (MDRD)with 24 h urinary creatinine clearance (CrCl24h), as a reference method. Method: 125 samples of 61 critically ill patients (each one with CG,MDRD y CrCl24hvalues) were classified in one of the five stages of the National Kidney Foundation (NKF) according to CrCl24h. Dosage discrepancies for each antibiotic based on CG y MDRD were studied in reference to CrCl24hby percentage agreement and weighted kappa. At each of the NKF stages, daily dosage differences (∆=DosisCG-DosisCrCl24h;∆=DosisMDRD-DosisCrCl24h) and percentage of samples with dosage discrepancies by CG and MDRD in reference to CrCl24h were calculated. Results: There were no statistically significant differences between the two prediction formulae in respect to CrCl24h, achieving good degrees of concordance. Deviation percentages fluctuated between15.2% and 28% and occurred mainly by under dosing on stages 1and 2 and by overdosing on stages 4 and 5.Conclusions: The two renal function prediction formulae can be indistinctly used to optimize the â-lactam antibiotics dose regimen, CGbeing the easiest one (AU)

Descripción del proceso de certificación ISO 9001/2000 en el área de nutrición parenteral / No disponible

Objetivo: Garantizar la calidad y seguridad e incrementar la satisfacción del usuario ha llevado a organizaciones del ámbitosanitario a integrar un sistema de gestión de calidad en su estructura. Este trabajo describe el proceso de implantación dela norma UNE-EN-ISO-9001/2000 en el área de nutriciónparenteral.Método: Un grupo multidisciplinar definió el alcance de la norma, centrándose en transcripción, acondicionamiento, dispensacióny control microbiológico.Resultados: Se elaboró un procedimiento detallando secuencialmente los circuitos y actividades asociadas, el personal responsable y las pautas de actuación a seguir. Se establecieron indicadoresde calidad y de actividad.Conclusiones: Este proceso ha permitido establecer un sistema normalizado cuyos procesos están perfectamente descritos y documentados, logrando la trazabilidad y supervisión de las fases.Al no disponer de histórico de los datos actualmente obtenidos, no es posible establecer una comparación directa; por tanto, deberá analizarse su evolución en un futuro

Objective: In order to guarantee quality and safety and to increase user satisfaction, healthcare organisations have integratedquality management systems into their structures. This study describes the process for introducing the UNE-EN-ISO-9001/2000 standard in the parenteral nutrition area.Method: A multidisciplinary group established the scope of the standard, focusing on transcription, preparation, dispensation and microbiological control.Results: A detailed procedure describing the sequences of circuits and associated activities, the responsible staff and the action guidelines to be followed was established. Quality and activity markers were also established.Conclusions: This process has enabled a standard system to be implemented, with its operation perfectly described and documented, allowing its stages to be traceable and supervised. As there is no record of the data obtained beforehand, no direct comparison can be made; its evolution must therefore be analysed inthe future