A complexity scale for clinical trials from the perspective of a pharmacy service.

OBJECTIVE: To establish a method for evaluating the complexity of clinical trials (CTs) from the perspective of a pharmacy service (PS) and to analyse the complexity of CTs carried out in a tertiary level hospital. METHODS: An observational, prevalence and retrospective study was carried out in a Spanish tertiary level hospital during the period 2008-2013. A scale of complexity was developed, whose internal consistency was determined by Cronbach's alpha. The study involved five steps: an analysis of the activities involved, score allocation to the activities, identification of CTs started in the study period, data collection and assessment of the complexity. Three complexity levels were determined: low, medium and high. The variables calculated were mean overall complexity, mean complexity per medical specialty, per pathology, per phase of CT, per initiation year and percentage of CTs by complexity level. RESULTS: Cronbach's alpha of the scale of complexity was 0.738. The two most influential items were dose preparation and number of professionals involved. 55.0% of CTs were in the medium level of complexity and 12.1% of CTs were in the high level. The mean complexity of CTs studied was 13.3±4.7 (median 12, range 6-32). Statistically significant differences were found in the complexity values between CTs of different medical specialties, pathologies, phase and dose preparation in the PS (p<0.001). CONCLUSIONS: The scale designed to evaluate the complexity of CTs had internal consistency. More than half of the CTs are in the medium level if complexity. The largest number of CTs with a high level of complexity were in rheumatology and oncology.

Implantación de consultas externas monográficas de atención farmacéutica en un servicio de farmacia hospitalaria / Implementation of specialized pharmaceutical care hospital outpatient clinics in a hospital pharmacy department

Objetivo: Describir la organización asistencial de Consultas Externas Monográficas de Atención Farmacéutica de un Servicio de Farmacia Hospitalaria, evaluar su calidad asistencial y la calidad percibida por los pacientes externos. Método: Estudio observacional retrospectivo en un servicio de farmacia de un hospital de nivel terciario durante tres períodos (años 2010, 2013 y 2016); descripción de la organización asistencial a nivel de estructura, recursos humanos, recursos materiales y procedimientos de trabajo; evaluación de la calidad asistencial mediante el análisis de tres variables de procedimiento: cumplimiento cita previa, tiempo de espera y documentación de la atención farmacéutica; evaluación de la calidad percibida por los pacientes externos mediante encuestas de satisfacción; análisis estadístico comparativo de medias (t Student) y proporciones (chi cuadrado Pearson). Resultados: 15 consultas monográficas abiertas atendidas por 18 farmacéuticos; entre el período inicial y el período final del estudio (2010 vs. 2016) el cumplimiento de cita previa fue del 61,3% vs. 88,8% (p< 0001), el tiempo de espera fue 27,6±12,1 vs. 12,1±5,4 minutos (p< 0,0001), la documentación de la atención farmacéutica en la historia clínica del 2,3% vs. 9,81% (p< 0,0001) y la satisfacción global percibida por los pacientes del 6,63±2,36 vs. 9,16±1,27 (p< 0,01). Conclusiones: El modelo de Consulta Externa Monográfica de Atención Farmacéutica expuesto, centrado en el paciente y con continuidad asistencial, ha mejorado la calidad asistencial y la calidad percibida por los pacientes y se encuentra en condiciones óptimas para investigar su aportación a los resultados en salud del paciente y al sistema sanitario a través de una mejor calidad, seguridad y eficiencia de la farmacoterapia (AU)

Objective: To describe the organization of patient care into Specialized Pharmaceutical Care Hospital Outpatient Clinics in a Hospital Pharmacy Department, to evaluate their healthcare quality, and the quality perceived by outpatients. Method: A retrospective observational study in a High-Level Hospital Pharmacy Department during three periods (years 2010, 2013 and 2016); description of the organization at the levels of structure, human resources, material resources and working procedures; evaluation of healthcare quality through the analysis of three variables in terms of procedure: prior appointment compliance, waiting time and documentation of pharmaceutical care; evaluation of quality perceived by outpatients through a satisfaction survey; comparative statistical analysis of means (Student's t) and proportions (Pearson's chi square). Results: Fifteen (15) specialized outpatient clinics were opened and managed by 18 pharmacists; between the initial and final periods of the study (2010 vs. 2016), the compliance with previous appointments was of 61.3% vs. 88.8% (p < 0001), waiting time was 27.6±12.1 vs. 12.1±5.4 minutes (p < 0.0001), documentation of pharmaceutical care in the clinical record was of 2.3% vs. 9.81% (p < 0.0001), and the overall satisfaction perceived by the patients was 6.63±2.36 vs. 9.16±1.27 (p< 0.01). Conclusions: The model of Specialized Pharmaceutical Care Hospital Outpatient Clinics exposed, focused on the patient and with continuity of care, has improved the quality of care and the quality perceived by the patients and it´s in optimal conditions to investigate its contribution on health outcomes and on the health system through a better quality, safety and efficiency of pharmacotherapy (AU)

Implementation of Specialized Pharmaceutical Care Hospital Outpatient Clinics in a Hospital Pharmacy Department.

OBJECTIVE: To describe the organization of patient care into Specialized Pharmaceutical Care Hospital Outpatient Clinics in a Hospital Pharmacy Department, to evaluate their healthcare quality, and the quality  perceived by outpatients. METHOD: A retrospective observational study in a High-Level Hospital Pharmacy Department during three periods (years 2010, 2013 and 2016); description of  the organization at the levels of structure, human resources, material resources  and working procedures; evaluation of healthcare quality through the analysis of  three variables in terms of procedure: prior appointment compliance, waiting  time and documentation of pharmaceutical care; evaluation of quality perceived  by outpatients through a satisfaction survey; comparative statistical analysis of  means (Student's t) and proportions (Pearson's chi square). RESULTS: Fifteen (15) specialized outpatient clinics were opened and managed by 18 pharmacists; between the initial and final periods of the study (2010 vs. 2016), the compliance with previous appointments was of 61.3% vs. 88.8% (p <0001), waiting time was 27.6±12.1 vs. 12.1±5.4 minutes (p  <0.0001), documentation of pharmaceutical care in the clinical record was of  2.3% vs. 9.81% (p <0.0001), and the overall satisfaction perceived by the  patients was 6.63±2.36 vs. 9.16±1.27 (p <0.01). CONCLUSIONS: The model of Specialized Pharmaceutical Care Hospital Outpatient  Clinics exposed, focused on the patient and with continuity of care, has improved the quality of care and the quality perceived by the patients and it´s in optimal conditions to investigate its contribution on health outcomes and on the health system through a better quality, safety and efficiency of pharmacotherapy.

Objetivo: Describir la organización asistencial de Consultas Externas Monográficas de Atención Farmacéutica de un Servicio de Farmacia Hospitalaria, evaluar su calidad asistencial y la calidad percibida por los pacientes externos.Método: Estudio observacional retrospectivo en un servicio de farmacia de un hospital de nivel terciario durante tres períodos (años 2010, 2013 y 2016); descripción de la organización asistencial a nivel de estructura, recursos humanos, recursos materiales y procedimientos de trabajo; evaluación de la calidad asistencial mediante el análisis de tres variables de procedimiento: cumplimiento cita previa, tiempo de espera y documentación de la atención farmacéutica; evaluación de la calidad percibida por los pacientes externos mediante encuestas de satisfacción; análisis estadístico comparativo de  medias (t Student) y proporciones (chi cuadrado Pearson).Resultados: 15 consultas monográficas abiertas atendidas por 18 farmacéuticos; entre el período inicial y el período final del estudio (2010 vs. 2016) el cumplimiento de cita previa fue del 61,3% vs. 88,8% (p<0001), el tiempo de espera fue 27,6±12,1 vs. 12,1±5,4 minutos (p<0,0001), la documentación de la atención farmacéutica en la historia clínica del 2,3% vs. 9,81% (p<0,0001) y la satisfacción global percibida por los pacientes del 6,63±2,36 vs. 9,16±1,27 (p<0,01).Conclusiones: El modelo de Consulta Externa Monográfica de Atención Farmacéutica expuesto, centrado en el paciente y con continuidad asistencial, ha mejorado la calidad asistencial y la calidad percibida por los pacientes y se encuentra en condiciones óptimas para investigar su aportación a los resultados en salud del paciente y al sistema sanitario a través de una mejor calidad, seguridad y eficiencia de la farmacoterapia.