Complicaciones gastrointestinales asociadas a quimioterapia de acondicionamiento para trasplante autólogo en pacientes con mieloma múltiple / Gastrointestinal complications associated with conditioning chemotherapy for autologous transplantation in patients with multiple mieloma

Objetivo: Determinar la prevalencia de mucositis oral (MO) y su gravedad en pacientes con mieloma múltiple (MM) sometidos a trasplante antólogo de sangre periférica (TASP) en nuestro centro. Otros objetivos son describir la duración de MO, utilización de Nutrición Parenteral Total (NPT) y analgesia, posibles infecciones y determinar la prevalencia de efectos adversos gastrointestinales (EA GI). Métodología: Estudio observacional, retrospectivo y longitudinal en pacientes con MM, sometidos a TASP acondicionado con melfalán a altas dosis. La variable principal estudiada fue la presencia de MO y su gravedad. Las variables secundarias fueron: duración de la MO, enfermedad peridontal previa (EPP), el tratamiento con NPT y con analgésicos y la presencia de infecciones. Resultados: Se incluyeron 34 pacientes en el estudio. El 71% (24/34) del total presentó MO y, de estos, el 42% (10/24) MO grave. El 38% (13/34) del total requirió de NPT, lo cual fue significativamente superior en el grupo de pacientes con MO grave (p<0,05). De los pacientes con MO, el 96% (23/24) requirió tratamiento analgésico sistémico. El 88% (30/34) y el 76% (26/34) del total, presentaron diarrea y náuseas y vómitos (N/V) respectivamente. Conclusiones: La MO tiene una alta prevalencia en los pacientes tratados con melfalán a dosis mieloablativas como acondicionamiento para TASP en nuestro hospital. La única variable que se relacionó con la presencia de MO fue la EPP. Otros EA GI que también tienen una alta prevalencia son la diarrea y N/V.(AU)

Objective: To determine the prevalence of oral mucositis (OM) and its severity in patients of multiple myeloma (MM) who had a procedure of autologous transplant of hematopoietic cells in our center. Other objectives are to describe the duration of MO, the use of Total Parenteral Nutrition (TPN) and analgesia, possible infections and determine the prevalence of gastrointestinal adverse effects (GI AE).Methodology: Observational, retrospective, and linear study of patients with multiple myeloma that went through conditioning myeloablative therapy and, after that, an autologous transplant of hematopoietic cells. Main variable was made the presence of OM and its duration. Secondary variables were OM degree, previous periodontal disease (PPD) parenteral nutrition and analgesic treatments and whether or not there was presence of infections. Results: 34 patients were included in the study. 71% (24/34) had OM and, among those, in 42% of cases (10/24) OM was severe. 38% (13/34) needed parenteral nutrition, with numbers significantly higher when it came to the ones affected by severe OM (p<0.05). 96% (23/24) of OM patients needed systemic analgesic therapy. 88% (30/34) and 76% (26/34) of all patients presented diarrhea and nausea and vomits, respectively. Conclusions: OM has a high prevalence in patients treated with Melphalan in myeloablative doses as a preparation for an autologous transplant of hematopoietic cells in our hospital. The only variable related to the presence of OM was previous mouth disease. More IG AE with high prevalence are diarrhea and nausea and vomits.(AU)

[Assessing quality in the process of using hazardous drugs-prescription and preparation]. / Evaluación de la calidad en el proceso de utilización de fármacos peligrosos: prescripción y preparación.

OBJECTIVE: To evaluate the quality of cytotoxic drug prescription based on the results of an interventional pharmaceutical program and the quality of the final product based on quality-control prior to preparation. STUDY PERIOD: July 2002-March 2003. Hazardous drug prescription was evaluated through an analysis of pharmaceutical interventions during therapeutical monitoring. Depending on repercussion in patients, they were classified in three categories (treatment optimization, resource optimization or criteria unification). Data obtained from manual quality control programs prior to hazardous drug preparation were evaluated. RESULTS: Sixty-four interventions were made (9 interventions per 100 prescriptions): 55% were classified as treatment optimization, 28% as resource optimization and 17% as criteria unification. A total of 66% of the interventions focused on treatment optimization were caused by prescription errors. Ninety-seven per cent were accepted. Out of 2,074 preparations, 1,951 were evaluated (94.9%). A 5.1% of non-evaluated preparations were due to a lack of registration and 0.8% to violations in the established protocol. CONCLUSIONS: Results of the interventional Pharmaceutical program show that an assisted prescription system is necessary, not only to detect prescription errors but also to prevent them. Manual controls in different stages of the process are useful and they should be complementary to other more reliable dosification controls.

Evaluación de la calidad en el proceso de utilización de fármacos peligrosos: prescripción y preparación / Assesing quality in the process of using hazarous drugs-prescription and preparation

Objetivo: Evaluar la calidad de la prescripción de citostáticos a partir de los resultados obtenidos en el programa de intervenciones farmacéuticas y la calidad de la preparación mediante un control de calidad realizado de forma previa a la elaboración. Métodos: Periodo de estudio: julio 2002-marzo 2003. Prescripción: se evaluó mediante el análisis de las intervenciones farmacéuticas realizadas durante la monitorización terapéutica de los tratamientos con fármacos peligrosos. Para su evaluación se clasificaron en 3 categorías según la repercusión en el paciente (optimización del tratamiento, optimización de recursos, unificación de criterios). Preparación: se evaluaron los registros obtenidos en el programa de control de calidad manual, previo a la elaboración de las preparaciones de fármacos peligrosos. Resultados: Se realizaron 64 intervenciones (9 intervenciones por cada 100 prescripciones): 55% fueron para optimizar el tratamiento, 28% para optimizar recursos, 17% para unificar criterios. De las intervenciones enfocadas a optimizar el tratamiento, un 66% fueron por errores de prescripción. El 97% de las intervenciones fueron aceptadas. De las 2.074 preparaciones realizadas se evaluaron 1.951 (94,9%). De las preparaciones no evaluadas, un 5,1% fue por falta de registro y un 0,8% por falta de cumplimiento del protocolo establecido. Conclusiones: Los resultados obtenidos en el programa de intervenciones farmacéuticas evidencian la necesidad de implantar un sistema de prescripción asistida, que nos permitirá actuar no sólo en la detección de errores de prescripción, sino en su prevención. La realización de controles manuales en diferentes puntos del proceso de elaboración resulta útil y debería ser una medida complementaria a otros controles más fiables de dosificación

Objective: To evaluate the quality of cytotoxic drug prescription based on the results of an interventional pharmaceutical program and the quality of the final product based on quality-control prior to preparation. Methods: Study period: July 2002-March 2003. Hazardous drug prescription was evaluated through an analysis of pharmaceutical interventions during therapeutical monitoring. Depending on repercussion in patients, they were classified in three categories (treatment optimization, resource optimization or criteria unification). Data obtained from manual quality-control programs prior to hazardous drug preparation were evaluated. Results: Sixty-four interventions were made (9 interventions per 100 prescriptions): 55% were classified as treatment optimization, 28% as resource optimization and 17% as criteria unification. A total of 66% of the interventions focused on treatment optimization were caused by prescription errors. Ninety-seven per cent were accepted. Out of 2,074 preparations, 1,951 were evaluated (94.9%). A 5.1% of non-evaluated preparations were due to a lack of registration and 0.8% to violations in the established protocol. Conclusions: Results of the interventional pharmaceutical program show that an assisted prescription system is necessary, not only to detect prescription errors but also to prevent them. Manual controls in different stages of the process are useful and they should be complementary to other more reliable dosification controls

[Detection and classification of medication errors at Joan XXIII University Hospital]. / Detección y clasificación de errores de medicación en el Hospital Universitari Joan XXIII.

INTRODUCTION: Medication errors are multifactorial and multidisciplinary, and may originate in processes such as drug prescription, transcription, dispensation, preparation and administration. The goal of this work was to measure the incidence of detectable medication errors that arise within a unit dose drug distribution and control system, from drug prescription to drug administration, by means of an observational method confined to the Pharmacy Department, as well as a voluntary, anonymous report system. The acceptance of this voluntary report system's implementation was also assessed. MATERIAL AND METHODS: A prospective descriptive study was conducted. Data collection was performed at the Pharmacy Department from a review of prescribed medical orders, a review of pharmaceutical transcriptions, a review of dispensed medication and a review of medication returned in unit dose medication carts. A voluntary, anonymous report system centralized in the Pharmacy Department was also set up to detect medication errors. RESULTS: Prescription errors were the most frequent (1.12%), closely followed by dispensation errors (1.04%). Transcription errors (0.42%) and administration errors (0.69%) had the lowest overall incidence. Voluntary report involved only 4.25% of all detected errors, whereas unit dose medication cart review contributed the most to error detection. CONCLUSIONS: Recognizing the incidence and types of medication errors that occur in a health-care setting allows us to analyze their causes and effect changes in different stages of the process in order to ensure maximal patient safety.