Standardization and Chemical Characterization of Intravenous Therapy in Adult Patients: A Step Further in Medication Safety.

BACKGROUND: Intravenous drug administration is associated with potential complications, such as phlebitis. The physiochemical characteristics of the infusate play a very important role in some of these problems. AIM: The aim of this study was to standardize the dilutions of intravenous drugs most commonly used in hospitalized adult patients and to characterize their pH, osmolarity and cytotoxic nature to better guide the selection of the most appropriate vascular access. METHODS: The project was conducted in three phases: (i) standardization of intravenous therapy, which was conducted using a modified double-round Delphi method; (ii) characterization of the dilutions agreed on in the previous phase by means of determining the osmolarity and pH of each of the agreed concentrations, and recording the vesicant nature based on the information in literature; and (iii) algorithm proposal for selecting the most appropriate vascular access, taking into account the information gathered in the previous phases. RESULTS: In total, 112 drugs were standardized and 307 different admixtures were assessed for pH, osmolarity and vesicant nature. Of these, 123 admixtures (40%), had osmolarity values >600 mOsm/L, pH < 4 or > 9, or were classified as vesicants. In these cases, selection of the most suitable route of infusion and vascular access device is crucial to minimize the risk of phlebitis-type complications. CONCLUSIONS: Increasing safety of intravenous therapy should be a priority in the healthcare settings. Knowing the characteristics of drugs to assess the risk involved in their administration related to their physicochemical nature may be useful to guide decision making regarding the most appropriate vascular access and devices.

[Recommendations for the safety preparation of sterile medicines in medical wards]. / Recomendaciones para la preparación de medicamentos estériles en las unidades de enfermería.

OBJECTIVE: To develop a recommendations guide about the preparation of sterile medicines in medical wards, and to figure out the current situation of different Spanish hospitals, regarding the preparation of sterile medicines outside the pharmacy. METHODS: The authors reviewed the available international guidelines in order to summarize the main quality recommendations. To know about the current situation in Spanish hospitals, a 30 questions survey was designed and spread to 500 different hospitals. Answers were analysed with SurveyMonkey® platform in the period February-July 2012. RESULTS: Based on the literature review, the authors agreed a recommendations list for the safe preparation of sterile medicines in medical wards, which was structured in 8 sections. Regarding the survey results, 8.4% of the hospitals answered, showing a great variability among centres in the quality requirements for sterile compounding outside the pharmacy. It should be pointed out the lack of assigned areas for drug preparation in wards, the lack of protocols to discern which kind of medicines can be compounded in wards as well as the poor recommendations about garment and aseptic technique. CONCLUSIONS: The authors confirm the absence of qualified practice standards to be applied in the preparation of sterile medicines in medical wards, as well as the great variability of diary practice. The implementation of quality and safety recommendations in the preparation of sterile medicines in medical wards may contribute to improve patient safety.

Recomendaciones para la preparación de medicamentos estériles en las unidades de enfermería / Recommendations for the safety preparation of sterile medicines in medical wards

Objetivo: Elaborar una guía de recomendaciones de preparación de medicamentos estériles en las unidades de enfermería, así como averiguar la situación actual de las condiciones de preparación en distintos hospitales españoles mediante una encuesta. Material y métodos: Se llevó a cabo una revisión bibliográfica de las recomendaciones internacionales publicadas y se elaboró un check-list de criterios de calidad. Para conocer la situación actual en los hospitales españoles, se diseñó una encuesta on-line de 30 preguntas dirigida al personal de enfermería que se ha difundido a 500 centros hospitalarios. Las respuestas auto cumplimentadas en el periodo de estudio (Febrero-Junio 2012), se analizaron con la aplicación Survey monkey®. Resultados: En base a la revisión, los autores consensuaron un listado de recomendaciones para la preparación segura de medicamentos estériles en unidades de enfermería, estructurado en 8 apartados. En cuanto a los resultados dela encuesta, respondieron un 8,4% de los centros, mostrando gran variabilidad en los requerimientos de calidad para la preparación de estériles en las plantas. Es destacable la ausencia de zonas designadas para la preparación en las unidades, la falta de protocolos sobre cuáles son los preparados estériles que pueden o no prepararse en planta y la escasez de normas en indumentaria y comportamiento para asegurar la asepsia. Conclusiones: Se constata la ausencia de estándares de práctica reconocidos que se apliquen de forma general en la preparación de medicamentos estériles en planta, así como una gran variabilidad en la práctica diaria. La aplicación de recomendaciones contrastadas de calidad y seguridad para la preparación de medicamentos estériles en las unidades de enfermería, puede contribuir a asegurar la asepsia de las preparaciones y disminuir los errores de medicación en planta

Objective: To develop a recommendations guide about the preparation of sterile medicines in medical wards, and to figure out the current situation of different Spanish hospitals, regarding the preparation of sterile medicines outside the pharmacy. Methods: The autors reviewed the available international guidelines in order to summarize the main quality recommendations. To know about the current situation in Spanish hospitals, a 30 questions survey was designed and spread to 500 different hospitals. Answers were analysed with Survey monkey® platform in the period February-July 2012. Results: Based on the literature review, the authors agreed a recommendations list for the safe preparation of sterile medicines in medical wards, which was structured in 8 sections. Regarding the survey results, 8.4% of the hospitals answered, showing a great variability among centres in the quality requirements for sterile compounding outside the pharmacy. It should be pointed out the lack of assigned areas for drug preparation in wards, the lack of protocols to discern which kind of medicines can be compounded inwards as well as the poor recommendations about garment and aseptic technique. Conclusions: The authors confirm the absence of qualified practice standards to be applied in the preparation of sterile medicines in medical wards, as well as the great variability of diary practice. The implementation of quality andsafety recommendations in the preparation of sterile medicines in medical wards may contribute to improve patient safety

Validación de la técnica aséptica de elaboración de nutrición parenteralen un servicio de farmacia según el capítulo 797 de la USP / Validation of aseptic technique of parenteral nutrition compounding in a pharmacy service according to USP chapter 797

Introducción: En el proceso de elaboración de nutrición parenteral se debe garantizar que el personal de enfermería utiliza una técnica aséptica adecuada. En el capítulo 797 de la United States Pharmacopeia se clasifican los niveles de riesgo de las preparaciones estériles y se definen los requerimientos que se deben cumplir en la elaboración. Objetivo: Describir el desarrollo de un procedimiento de validación de la técnica aséptica utilizada por el personal de enfermería que elabora nutriciones parenterales en el área de elaboración del Servicio de Farmacia según las recomendaciones del capítulo 797 de la United States Pharmacopeia. Métodos: Se revisó el capítulo 797 de la United States Pharmacopeia y se clasificaron las nutriciones parenterales como preparaciones de riesgo medio de contaminación microbiológica. Resultados: Se adaptaron las recomendaciones de la United States Pharmacopeia para mezclas de riesgo medio y se estableció un procedimiento de validación de la técnica aséptica para la elaboración de las nutriciones parenterales. Discusión: El procedimiento de validación de la técnica aséptica permite validar la calidad del manejo aséptico del personal de enfermería. El procedimiento se ha incorporado a la práctica habitual, realizándose de forma mensual por el personal de enfermería del área de nutrición (AU)

INTRODUCTION: During the process of parenteral nutrition preparation, aseptic techniques by nursing staff must be guaranteed. Chapter 797 of the United States Pharmacopeia classifies the risk levels of sterile compounding and defines the requirements that must be followed throughout the compounding. OBJECTIVE: To describe the development of an aseptic technique validation procedure for nurses who compound parenteral nutrition at the compounding area Pharmacy Service according to Chapter 797 United States Pharmacopeia guidelines. MATERIAL AND METHODS: Chapter 797 United States Pharmacopeia was reviewed and parenteral nutritions were classified as medium risk level compounded sterile preparations. RESULTS: We adapted the United States Pharmacopeia guidelines for medium risk level compounded sterile preparations and we performed a procedure of aseptic technique validation for parenteral nutrition compounding. CONCLUSIONS: The aseptic technique validation procedure allows the validation of aseptic management quality of nursing staff. The procedure has been incorporated into practice and is performed monthly by the nursing staff in the nutrition area (AU)