Development and Internal Validation of a Questionnaire Assessing Predisposition to Nonadherence to Immunosuppressive Medication in Kidney Pretransplant Patients.

BACKGROUND: After kidney transplant, nonadherence to immunosuppressive therapy is the main cause of impaired kidney function and graft loss. The objective of this study was the development and internal validation of a clinical questionnaire for assessing the predisposition to adherence to immunosuppressive therapy in kidney pretransplant patients. METHODS: Multicenter prospective study conducted in 7 kidney hemodialysis and 6 kidney transplant centers of 3 Brazilian state capitals. Kidney transplant candidate patients of both sexes and >18-y-old were included. Retransplanted patients were excluded. A 72-item pilot version of the questionnaire, created through literature review complemented with a focus group of 8 kidney pretransplant patients, was administered to 541 kidney transplant candidate patients. Factor analysis with varimax rotation was used for questionnaire development. Internal validity evaluation used Cronbach's alpha and test-retest reliability. Construct validity was assessed by differentiation by known groups. RESULTS: The final questionnaire, named Kidney AlloTransplant Immunosuppressive Therapy Adherence (KATITA) Questionnaire, consisting of 25 items in 3 dimensions, presented good internal consistency reliability (Cronbach's alpha 0.81). The 3 dimensions and respective Cronbach's alpha were "Carelessness" (14 items, 0.81), "Skepticism" (6 items, 0.57), and "Concern" (5 items, 0.62). The interdimension correlation matrix showed low correlation coefficients (<0.35). Test-retest reliability, evaluated with 154 patients, showed an intraclass correlation coefficient of 0.62 (moderate agreement). The scale showed construct validity. CONCLUSIONS: The KATITA-25 questionnaire is the first psychometric instrument for evaluation of predisposition to nonadherence to immunosuppressive medication in candidate patients for kidney transplant in the pretransplant setting.

Pharmaceutical interventions and factors associated with their acceptance in intensive care units in Brazil / Intervenciones farmacéuticas y factores asociados a su aceptación en unidades de cuidados intensivos en Brasil

Objetivo: El propósito de este estudio es evaluar las intervenciones farmacéuticas (IF) realizadas sobre PRM y los factores asociados a su aceptación. Método: Se trata de un estudio descriptivo y transversal que analizó las IF realizadas a pacientes adultos de dos UCI de Fortaleza, Brasil, en 2019. Las IF se analizaron en las categorías cantidad de fármaco y estrategia farmacológica, utilizando la clasificación propuesta por Sabater et al. Los fármacos se clasificaron además por el Sistema de Clasificación Anatómica, Terapéutica, Química y por la clasificación de Fármacos de Alta Vigilancia (FAV). Resultados: Se incluyeron 305 pacientes, siendo la mayoría del sexo masculino (55,1 %), ancianos (52,8 %) y atendidos en la UCI quirúrgica (51,4 %). Se analizaron 1.317 IF y se aceptaron el 88,0 %, siendo la sustitución de uno o más fármacos (28,0 %) y la adición de uno o más fármacos (27,7 %) las más frecuentes. La clase terapéutica más prevalente fue antiinfeccioso de uso sistémico (24,1 %) y los FAV estuvieron implicados en el 21,7 % de las IF. Se observó asociación entre las IF aceptadas e ingreso en UCI clínica (p<0,0001), FAV (p=0,0013), sustitución de uno o más fármacos (p=0,0062) y la clase sustitutos sanguíneos y soluciones de perfusión (p= 0,0187). Conclusiones: Se realizaron y aceptaron un elevado número de IF, lo que refuerza la importancia del farmacéutico en la revisión de las prescripciones médicas en UCI. (AU)

Objective: The purpose of this study is to evaluate the pharmaceutical interventions (PI) performed in PRM and the factors associated with their acceptance.Method: This is a descriptive and cross-sectional study that analyzed PIs performed on adult patients from two ICUs in Fortaleza, Brazil, in 2019. PIs were analyzed in the categories quantity of drug and pharmacological strategy, using the classification proposed by Sabater et al. The drugs were also classified by the Anatomical, Therapeutic, and Chemical Classification System and by the High Surveillance Drugs (FAV) classification.Results: 305 patients were included, most of them male (55.1 %), elderly (52.8 %) and treated in the surgical ICU (51.4 %). 1,317 PIs were analyzed and 88.0 % were accepted, being to replace one or more drugs (28.0 %), to add one or more drugs (27.7 %) and to change the dose (24.8 %) the most frequent types. The most prevalent therapeutic class was anti-infectives for systemic use (24.1 %) and AVFs were involved in 21.7 % of the PIs. An association was observed between PIs accepted and admission to the clinical ICU (p<0.0001), AVF (p=0.0013), substitution of one or more drugs (p=0.0062) and the class of blood substitutes and perfusion solutions. (p= 0.0187).Conclusions: A high number of PIs were performed and accepted, which reinforces the importance of the pharma-cist in the review of medical prescriptions in the ICU. (AU)

[Analysis of similar drug labeling: potential medication errors]. / Análise da rotulagem de medicamentos semelhantes: potenciais erros de medicação.

OBJECTIVE: This study aimed to examine drug packaging and labeling, identifying similarities among them that may lead to medication errors, which may occur by unintentional substitution, in different sectors of the pharmacy of a university hospital in northeastern Brazil. METHODS: Cross-sectional observational study, which included 300 pharmaceutical presentations (150 pairs) that were photographed from May to December 2010. Concordance analysis of data related to the pictures of possibly similar packaging and labels was validated using the Kappa index. RESULTS: Of all drugs evaluated (n = 150), about 43% of "possibly similar drugs" were in the central pharmacy (n = 65) and were related to small-volume parenteral solutions. The strength of interobserver agreement in the category "very similar to each other" was considered "satisfactory" (Kappa = 0584) in 90.66% of the drugs evaluated (n = 136). The overall Kappa analysis of the study was 0.488. Variables with statistical significance were: "same color label or packaging", with the respective percentages for both primary and secondary packaging (52%-44%), p = 0.028; the variable "same color of drug presentation" obtained similar values and statistical significance to the previous variable; for the variable "same arrangement of words", the values found for both packages were close to 50%, p = 0.001; and for the variable "same color of the words", the percentages were: (50.7% - 44%) (p = 0.008). CONCLUSION: Our results indicate similarities related to the labeling of drugs with potential for errors, especially in dispensing, storage, and administration if preventive measures are not adopted.

Análise da rotulagem de medicamentos semelhantes: potenciais erros de medicação / Analysis of similar drug labeling: potential medication errors

OBJETIVO: Este trabalho objetivou analisar as embalagens e rótulos de medicamentos, identificando semelhanças entre os mesmos que possam conduzir a erros de medicação passíveis de ocorrer por troca, em diferentes setores da farmácia de um hospital universitário do nordeste do Brasil. MÉTODOS: Estudo observacional e transversal, que abrangeu 300 apresentações farmacêuticas, sendo (150 duplas) fotografadas no período de maio a dezembro de 2010. A análise de concordância dos dados referente às fotos de embalagens e rótulos possivelmente semelhantes foi validada utilizando o índice Kappa. RESULTADOS: Do total de medicamentos avaliados (n = 150), cerca de 43 por cento dos "possivelmente semelhantes" estavam na farmácia central (n = 65) e se relacionaram a soluções parenterais de pequeno volume. A força de concordância interobservadores na categoria "muito semelhante entre si" foi considerada "satisfatória" (índice Kappa = 0,584) em 90,66 por cento dos medicamentos avaliados (n = 136). A análise do Kappa geral do estudo foi de 0,488. As variáveis com significância estatística foram: "mesma cor do rótulo ou embalagem", com os respectivos percentuais, tanto para embalagens primárias como secundárias (52 por cento-44 por cento), com p = 0,028. A variável "mesma cor das apresentações farmacêuticas" obteve valores e significância estatística semelhantes à variável anterior. Quanto à variável "mesma disposição dos dizeres", os valores encontrados para ambas as embalagens foram próximas a 50 por cento, com p = 0,001 e, para a variável "mesma cor dos dizeres", os percentuais encontrados foram: (50,7 por cento-44 por cento) (p = 0,008). CONCLUSÃO: Nossos resultados identificaram semelhanças relativas à rotulagem de medicamentos com potencial, principalmente, para erros de dispensação, armazenamento e administração se medidas preventivas não forem adotadas.

OBJECTIVE: This study aimed to examine drug packaging and labeling, identifying similarities among them that may lead to medication errors, which may occur by unintentional substitution, in different sectors of the pharmacy of a university hospital in northeastern Brazil. METHODS: Cross-sectional observational study, which included 300 pharmaceutical presentations (150 pairs) that were photographed from May to December 2010. Concordance analysis of data related to the pictures of possibly similar packaging and labels was validated using the Kappa index. RESULTS: Of all drugs evaluated (n = 150), about 43 percent of "possibly similar drugs" were in the central pharmacy (n = 65) and were related to small-volume parenteral solutions. The strength of interobserver agreement in the category "very similar to each other" was considered "satisfactory" (Kappa = 0584) in 90.66 percent of the drugs evaluated (n = 136). The overall Kappa analysis of the study was 0.488. Variables with statistical significance were: "same color label or packaging", with the respective percentages for both primary and secondary packaging (52 percent-44 percent), p = 0.028; the variable "same color of drug presentation" obtained similar values and statistical significance to the previous variable; for the variable "same arrangement of words", the values found for both packages were close to 50 percent, p = 0.001; and for the variable "same color of the words", the percentages were: (50.7 percent - 44 percent) (p = 0.008). CONCLUSION: Our results indicate similarities related to the labeling of drugs with potential for errors, especially in dispensing, storage, and administration if preventive measures are not adopted.