Implementation of safeguards to improve patient safety in chemotherapy

Purpose. To evaluate the effectiveness of safeguards introduced in the process of using cytostatic agents for increasing the safety of oncology patients. Methods. Prospective hospital study conducted in two stages, before and after the implementation of safeguards: staff training, standardized procedures, computerized prescription, pharmaceutical validation, implementation of bar codes, and a new manual on drug interactions. Medication errors (MEs) were actively recorded during the process of administering chemotherapy in the Medical Oncology Department. The study classified MEs by the stage of the medication process in which they occurred and assessed their severity. Results. 500 patients, 250 before implementing safeguards and 250 afterward, were included in this study . Out of all patients included before, 43.1% had at least 1 error, compared to 27% of those included later. The number of MEs detected before and after was 144 vs. 95: 125 vs. 55 prescription errors, 2 vs. 5 validation errors, 14 vs. 4 preparation errors, 3 vs. 1 dispensation errors and 0 vs. 30 administration errors. The number of MEs that reached the patient before and after safeguard implementation was 16.7% vs. 6.3%. After the safeguards were introduced, all MEs that could have caused harm or required monitoring of some kind were prevented. Conclusions. Implementing safeguards in the hospital’s cytostatic treatment cycle is useful for preventing MEs. Computerized prescription, pharmaceutical validation, and the creation/dissemination of proper work procedures are effective barriers that keep MEs from reaching the patient. Administering chemotherapy with a bar-code system facilitates detection error detection at this stage of the cycle and prevents them from reaching the patient (AU)

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Análisis de la efectividad de un protocolo de antiemesis implantado en la Unidad de Oncología / Analysis of the effectiveness of an antiemetic protocol used in an oncology division

Objetivo Analizar la efectividad de un protocolo antiemético en pacientes que reciben quimioterapia. Método Estudio prospectivo en pacientes con tumores sólidos con quimioterapia en el hospital de día de Oncología entre enero 2006–2007.Se realizó una revisión bibliográfica analizando las recomendaciones de guías de práctica clínica. Se calculó el potencial emetógeno según nivel Hesketh (NH), estableciendo la premedicación antiemética de cada esquema. Se evaluó la efectividad de un protocolo antiemético mediante una encuesta como método de medida de episodios eméticos y náuseas en fase aguda y retardada. Resultados Ciento setenta y dos pacientes cumplimentaron la encuesta, 13,4% vomitaron en fase aguda y 16,9% en retardada, mediana número de veces 2 (1–8) y 1 (1–5) respectivamente. Con esquemas NH 4–5 18,5% experimentaron vómitos en fase aguda y 20,2% en retardada; náuseas en fase aguda 46% y 38,4% en retardada. El control de vómitos en pacientes con esquemas NH=1–3 fue del 100% en fase aguda y de 91,7% en retardada; notificaron náuseas un 27% en fase aguda y 31% en retardada. Los factores que más contribuyeron a la presencia de vómitos y náuseas fueron potencial emetógeno (p<0,05), vómitos en ciclo anterior (p<0,05) y edad<50 p lt 0 002DiscusiónLa pauta propuesta es eficaz en el control de vómitos para esquemas NH=–3. En esquemas altamente emetógenos, el protocolo antiemético es también eficaz aunque la protección no es completa. Este protocolo parece no ser tan efectivo en el control de náuseas, aunque este es un síntoma subjetivo de valoración compleja que no se mide de forma sistemática en ensayos clínicos (AU)

Objective To analyse the effectiveness of an antiemetic protocol in patients receiving chemotherapy treatment. Method Prospective study in patients with solid tumours receiving chemotherapy in an oncology day hospital between January 2006 and 2007. We conducted a literature review and an evaluation of the recommendations of different clinical practice guidelines. The emetogenic potential was calculated according to the Hesketh level (HL), and the antiemetic premedication was determined for each regimen. We evaluated the effectiveness of an antiemetic protocol by using a survey as a method for measuring emetic episodes and nausea in the acute and delayed phases.Results172 patients completed the survey. 13.4% vomited in the acute phase and 16.9% in the delayed phase; the median number of times was 2 (1–8) and 1 (1–5) for each respective phase. With treatment regimens classed as HL 4-5, 18.5% experienced vomiting in the acute phase and 20.2% in the delayed phase, with 46% experiencing nausea in the acute phase and 38.4% in the delayed phase. Control of vomiting in patients with treatment regimens classed as HL 1-3 was 100% in acute phase and 91.7% in the delayed phase; nausea was reported by 27% in the acute phase and 31% in the delayed phase. The factors that contributed the most to the presence of vomiting and nausea were the emetogenic potential of the treatment regimen (p<0.05), vomiting in the previous cycle (p<0.05) and age younger than 50 years (p<0.002).Discussion The proposed antiemetic protocol is effective for controlling vomiting in chemotherapy regimens with an HL of 1-3. For highly emetogenic regimens, the antiemetic protocol is also effective, but protection is not complete. This protocol seems less effective for controlling nausea, although this is a subjective symptom which is difficult to assess and not routinely measured in clinical trials (AU)

Tratamiento con cetuximab en pacientes con cáncer colorrectal metastásico que no expresan el receptor del factor de crecimiento epidérmico / No disponible

Objetivo: Evaluar la respuesta a cetuximab en términos detiempo hasta progresión y supervivencia global en pacientes concáncer colorrectal (CCR) con determinación del receptor del factorde crecimiento epidérmico (EGFR) indetectable.Método: Se seleccionaron nueve pacientes con cetuximabEGFR negativo, confirmado mediante estudio inmunohistoquímico.Variables recogidas: datos demográficos, diagnóstico, tratamientosprevios, tiempo desde la primera metástasis hasta iniciocon cetuximab, reacciones adversas y marcadores tumorales. Larespuesta se monitorizó mediante marcadores tumorales y progresiónde la enfermedad. La evaluación de la calidad de vidamediante estado funcional de Karnofsky (KPS) o Eastern CooperativeOncology Group (ECOG).Resultados: 22% hombres (2/9) con una mediana de edadde 48 años (rango 31-63). La mediana de tiempo desde el diagnósticode enfermedad metastásica hasta inicio de tratamientocon cetuximab fue 19 meses (rango 12-48). Todos los pacienteshabían fracasado a un esquema que incluyó irinotecán, el 77,77%(7/9) también a uno con oxaliplatino. La mediana de ciclos concetuximab fue de 14 (rango 6-32). El principal efecto adverso fuela aparición de una erupción cutánea acneiforme presente en el100% de los casos. La mediana de tiempo hasta progresión fue 7(rango 3-16) meses y la supervivencia global 10,2 meses (rango 4-24). Los resultados en calidad de vida mostraron KPS entre 80-100% y ECOG < 2. Los resultados obtenidos en nuestro estudioen supervivencia global y tiempo hasta progresión son superioresa los del estudio pivotal, 10,2 vs. 8,6 meses y 7 vs. 4,1 meses respectivamente.Conclusiones: Con los resultados obtenidos se puede cuestionarla utilidad de la determinación de la expresión del EGFR, almenos mediante la técnica de inmuhistoquímica, como predictorde respuesta al tratamiento con cetuximab. Esto sugiere que laselección de los pacientes mediante la determinación rutinaria deeste receptor pudiera ser inapropiada, ya que excluye a pacientesque potencialmente pueden beneficiarse del tratamiento. No obstante,se requieren más ensayos clínicos en este ámbito que corroborenestas conclusiones

Objective: To evaluate the response to cetuximab, in terms oftime passed until disease progression and overall survival, inpatients with colorectal cancer (CRC) in which the epidermalgrowth factor receptor (EGFR) is undetectable.Method: Nine EGFR-negative patients (confirmed by animmunohistochemistry study), who were being treated with cetuximab,were selected. Variables collected: demographic data, diagnosis,previous treatments, time since first metastasis to start oftreatment with cetuximab, adverse events and tumour markers.The response was monitored using tumour markers and diseaseprogression. Well-being was assessed using the Karnofsky performancestatus (KPS) or that of the Eastern Cooperative OncologyGroup (ECOG).Results: 22% men (2/9) with a median age of 48 (31-63).The median time from being diagnosed with the metastatic diseaseto the start of treatment with cetuximab was 19 months (12-48). All patients had failed an irinotecan-based regime, 77.77%(7/9) had also failed one which included oxaliplatin. The mediannumber of cycles with cetuximab was 14 (6-32). The mainadverse event was the appearance of an acneiform rash in 100%of the cases. The median time until disease progression was 7months (3-16) and 10.2 months (4-24) for overall survival. Theresults for well-being showed a KPS of between 80-100% and anECOG of < 2. The results obtained in the present study for overallsurvival and time until disease progression are higher than thosein the pivotal study (10.2 compared to 8.6 months and 7 comparedto 4.1 months respectively). Conclusions: According to the results obtained, the use ofassessing the EGFR expression (by the immunohistochemistrytechnique at least), as a means of predicting response to treatmentwith cetuximab may be questioned. This suggests that selectingpatients using the routine assessment of this receptor is inappropriate,since it excludes patients who may potentially benefit fromthe treatment. However, more clinical trials are required in thisarea in order to confirm these conclusions

Impact of computerised chemotherapy prescriptions on the prevention of medication errors

OBJECTIVES: The authors sought to evaluate the impact of computerised chemotherapy prescription on the reduction of medication errors. The purpose of this study was to assess the incidence of errors present in electronic versus manual prescription. MATERIAL AND METHODS: The data gathered from computerised chemotherapy prescription sheets were submitted to a prospective analysis as cases of the intervention groups. The control group was comprised of the handwritten chemotherapy prescription sheets. Chemotherapy prescriptions for consecutive oncology patients were analysed by 2 independent examiners, who investigated errors of omission, commission, interpretation of dates, abbreviations and illegible handwriting. The proportion of treatment prescriptions containing one or more errors and the median of errors were calculated in order in both groups. RESULTS: At least one error was detected in 100% of the manual prescriptions and in 13% of computerised prescriptions (p < 0.001). The median of errors per computerised prescription was 0 (range: 0- 1), whereas in manual prescriptions the median was 5 (range: 1-12) (p < 0.001). Errors of omission were predominant in manual prescriptions. Errors of commission were limited to 1 case of unjustified cytostatic agent infra-dosage in a computerised prescription. This error was present in 3 cases in handwritten prescriptions and, in addition, 1 case of premedication drug substitution was detected. Errors of interpretation of the date, use of abbreviations and illegible handwriting were frequent among manual prescriptions and were absent from computerised prescriptions. CONCLUSIONS: Electronic chemotherapy prescription is a powerful tool. In this study it has been shown to decrease chemotherapy-related medication errors and ensure that safe chemotherapy practices were followed (AU)