Adecuación de la prescripción en pacientes mayores polimedicados en atención primaria. Ensayo clínico controlado aleatorizado por grupos PHARM-PC / Prescription appropriateness in elderly patients with polypharmacy in primary care: Cluster-randomized controlled trial PHARM-PC

Objetivos: Evaluar la efectividad de la revisión sistemática de medicación realizada por farmacéutico sobre medicaciones potencialmente inapropiadas (MPI), resultados en salud y costes. Diseño: Ensayo clínico prospectivo, abierto, controlado y aleatorizado por clústeres. Emplazamiento: Seis centros de atención primaria de las Islas Baleares. Participantes: Se incluyeron 42 clústeres (21 por grupo), y 549 pacientes de ≥ 65 años y ≥ 5 medicamentos crónicos, de los cuales 277 se asignaron al Grupo Intervención (GI) y 272 al Grupo Control (GC). Se excluyeron pacientes: institucionalizados, desplazados, atendidos habitualmente por la sanidad privada, o en atención domiciliaria. Intervención: Detección de MPI por parte del farmacéutico mediante combinación de métodos explícitos e implícitos y comunicación de las alternativas terapéuticas más apropiadas al médico prescriptor. Mediciones: Se evaluaron la proporción de pacientes con MPI y número medio de MPI/paciente (variables principales); así como morbilidad, mortalidad, y costes (variables secundarias). Análisis estadístico: Siguiendo el principio de intención de tratar, se compararon las variables cuantitativas y cualitativas mediante las pruebas t Student y X2, respectivamente. Los resultados se expresaron como diferencia de proporciones para variables cualitativas y diferencia de medias para cuantitativas, con los correspondientes intervalos de confianza 95% (IC 95%). Resultados: Después de la intervención, la proporción de pacientes con MPI disminuyó un 13,7% (IC 95%: 9,3; 18,2) más en GI que GC. El número medio de MPI/paciente y coste medio de MPI/paciente disminuyeron en 0,43 (IC 95%: 0,32; 0,54) y 72,11€ (IC 95%: 26,15; 118,06) más en GI que GC, respectivamente. Sin embargo, no se observaron diferencias estadísticamente significativas en morbilidad, mortalidad ni en costes de episodios asistenciales.(AU)

Objectives: To assess the effectiveness of a pharmacist-led systematic review of medications on: potentially inappropriate medications (PIM), health outcomes and costs. Design: Prospective, open, controlled and cluster-randomized clinical trial. Setting: Six primary care clinics from Balearic Islands. Participants: Forty-two clusters (21 per group), and 549 patients aged ≥65 years and ≥5 chronic medications were included; of which 277 were allocated to Intervention Group (IG) and 272 to Control Group (CG). Patients were excluded if they were: institutionalized, temporarily displaced, routinely monitored under private healthcare, or home care. Intervention: PIM detection by the pharmacist using a combination of explicit and implicit methods; and communication of the most appropriate therapeutic strategies to the physician. Measurements: Proportion of patients with PIM and mean number of PIM/patient (main outcomes); and morbidity, mortality, and costs (secondary outcomes) were assessed. Statistical plan: Following an intention-to-treat approach, quantitative and qualitative outcomes variables were compared by T-Student and Chi-square tests, respectively. Results were providing as difference in proportions for qualitative outcomes and difference in means for quantitative outcomes with respective 95% confidence intervals (95% CI). Results: After intervention, proportion of patients with PIM decreased by 13.7% (95% CI: 9.3; 18.2) more in IG than CG. Mean number of PIM/patient and mean cost of PIM/patient decreased by 0.43 (95% CI: 0.32; 0.54) and 72.11€ (95% CI: 26.15; 118.06) more in IG than CG, respectively. However, no statistically significant differences were observed in morbidity, mortality or costs of healthcare resources.(AU)

[Prescription appropriateness in elderly patients with polypharmacy in primary care: Cluster-randomized controlled trial PHARM-PC]. / Adecuación de la prescripción en pacientes mayores polimedicados en atención primaria. Ensayo clínico controlado aleatorizado por grupos PHARM-PC.

OBJECTIVES: To assess the effectiveness of a pharmacist-led systematic review of medications on: potentially inappropriate medications (PIM), health outcomes and costs. DESIGN: Prospective, open, controlled and cluster-randomized clinical trial. SETTING: Six primary care clinics from Balearic Islands. PARTICIPANTS: Forty-two clusters (21 per group), and 549 patients aged ≥65 years and ≥5 chronic medications were included; of which 277 were allocated to Intervention Group (IG) and 272 to Control Group (CG). Patients were excluded if they were: institutionalized, temporarily displaced, routinely monitored under private healthcare, or home care. INTERVENTION: PIM detection by the pharmacist using a combination of explicit and implicit methods; and communication of the most appropriate therapeutic strategies to the physician. MEASUREMENTS: Proportion of patients with PIM and mean number of PIM/patient (main outcomes); and morbidity, mortality, and costs (secondary outcomes) were assessed. STATISTICAL PLAN: Following an intention-to-treat approach, quantitative and qualitative outcomes variables were compared by T-Student and Chi-square tests, respectively. Results were providing as difference in proportions for qualitative outcomes and difference in means for quantitative outcomes with respective 95% confidence intervals (95% CI). RESULTS: After intervention, proportion of patients with PIM decreased by 13.7% (95% CI: 9.3; 18.2) more in IG than CG. Mean number of PIM/patient and mean cost of PIM/patient decreased by 0.43 (95% CI: 0.32; 0.54) and 72.11€ (95% CI: 26.15; 118.06) more in IG than CG, respectively. However, no statistically significant differences were observed in morbidity, mortality or costs of healthcare resources. CONCLUSIONS: PIM detection and recommendations provided by pharmacist could contribute to reduce significantly PIM and drug expenditure; but without reaching statistically significant differences in morbidity, mortality, and healthcare resources costs.

Intervención del farmacéutico en la prescripción potencialmente inapropiada en pacientes polimedicados: Protocolo ensayo clínico PHARM-PC / Pharmacist-led intervention on potentially inappropriate prescription in patients with polypharmacy: PHARM-PC clinical trial protocol

Objetivo: La polimedicación y la medicación potencialmente inapropiada (que presenta balance beneficio-riesgo desfavorable) son importantes preocupaciones respecto a los pacientes mayores en atención primaria,ya que pueden incrementar el riesgo de morbimortalidad y los costes sanitarios. Diversos estudios han evaluado el impacto de la revisión sistemáticade la medicación conducida por el farmacéutico sobre variables de adecuación, recursos sanitarios y/o costes. Sin embargo, no se han encontradoensayos controlados aleatorizados por clúster que evalúen globalmentetodas estas variables. El objetivo de este estudio es determinar el impactode una revisión sistemática de medicación conducida por el farmacéuticopara reducir el número medio y la proporción de pacientes con medicaciónpotencialmente inapropiada (objetivo principal), así como para reducir lamorbimortalidad y los costes (objetivos secundarios).Método: Se realizará un ensayo clínico abierto, controlado y aleatorizado por clústeres, donde los médicos de atención primaria, en representación de sus respectivos cupos de pacientes, serán aleatorizadosa recibir recomendaciones del farmacéutico para retirar medicacionespotencialmente inapropiadas detectadas mediante combinación de métodos implícitos y explícitos (grupo intervención) o no recibirlas (grupo control). Las variables primarias serán la proporción de pacientes y el númeromedio de medicaciones potencialmente inapropiadas por paciente. Lasvariables secundarias serán los recursos asistenciales frecuentados, proporción de pacientes fallecidos y días de supervivencia; y costes de medicamentos y de recursos asistenciales. (AU)

Objective: Polypharmacy and potentially inappropriate medications(that is, those associated with an unfavorable risk-benefit ratio) are common concerns in the context of elderly patients treated in primary care asthey may increase the risk of morbidity and mortality, as well as healthcare costs. Several studies have assessed the impact of pharmacist-ledsystematic reviews with respect to prescription appropriateness, healthoutcomes and/or costs. However, no cluster-randomized controlled trialhas been identified that provides an overall assessment of these variables.The objective is to determine the effectiveness of a pharmacist-led systematic medication review in reducing the mean number and proportion ofpatients on potentially inappropriate medications (primary goal); as wellas in decreasing morbidity and mortality and the cost of medications andthe use of healthcare resources (secondary goals).Method: An open-label, cluster-randomized controlled trial will beconducted; where primary care physicians will be randomized either toreceive (intervention group) or not to receive pharmacist recommendationsto withdraw potentially inappropriate medications detected through thecombined use of explicit and implicit criteria (control group). Primary endpoints will be the proportion of patients on potentially inappropriate medications and the mean number of such medications per patient. Secondaryendpoints will be healthcare resources used, the proportion of patientswho die and the mean number of days survived, as well as the cost ofmedications and cost of healthcare resources used. (AU)

Pharmacist-led intervention on potentially inappropriate prescription in patients with polypharmacy: PHARM-PC clinical trial protocol.

OBJECTIVE: Polypharmacy and potentially inappropriate medications (that  is, those associated with an unfavorable risk-benefit ratio) are common concerns in the context of elderly patients treated in primary care as they may increase the risk of morbidity and mortality, as well as  healthcare costs. Several studies have assessed the impact of pharmacist- led systematic reviews with respect to prescription appropriateness, health outcomes and/or costs. However, no cluster-randomized controlled  trial has been identified that provides an overall assessment of these  variables. The objective is to determine the effectiveness of a pharmacist- led systematic medication review in reducing the mean number and proportion of patients on potentially inappropriate medications (primary  goal); as well as in decreasing morbidity and mortality and the cost of  medications and the use of healthcare resources (secondary goals). METHOD: An open-label, cluster-randomized controlled trial will be conducted; where primary care physicians will be randomized either to receive (intervention group) or not to receive pharmacist  recommendations to withdraw potentially inappropriate medications  detected through the combined use of explicit and implicit criteria (control  group). Primary end-points will be the proportion of patients on potentially inappropriate medications and the mean number of such medications per  patient. Secondary endpoints will be healthcare resources used, the  proportion of patients who die and the mean number of days survived, as  well as the cost of medications and cost of healthcare resources used. CONCLUSIONS: In line with similar reports and based on our study´s design, we hope to obtain statistically significant reductions in the use  of potentially inappropriate medications and in medication costs overall.  We do not however expect to obtain significant reductions in  morbimortality or the cost of health resources employed.

Objetivo: La polimedicación y la medicación potencialmente inapropiada (que presenta balance beneficio-riesgo desfavorable) son  importantes preocupaciones respecto a los pacientes mayores en atención  primaria, ya que pueden incrementar el riesgo de morbimortalidad y los  costes sanitarios. Diversos estudios han evaluado el impacto de la revisión  sistemática de la medicación conducida por el farmacéutico sobre variables de adecuación, recursos sanitarios y/o costes. Sin embargo, no se han  encontrado ensayos controlados aleatorizados por clúster que evalúen  globalmente todas estas variables. El objetivo de este estudio es  determinar el impacto de una revisión sistemática de medicación  conducida por el farmacéutico para reducir el número medio y la  proporción de pacientes con medicación potencialmente inapropiada  (objetivo principal), así como para reducir la morbimortalidad y los costes  (objetivos secundarios).Método: Se realizará un ensayo clínico abierto, controlado y aleatorizado por clústeres, donde los médicos de atención primaria, en  representación de sus respectivos cupos de pacientes, serán aleatorizados a recibir recomendaciones del farmacéutico para retirar  medicaciones potencialmente inapropiadas detectadas mediante  combinación de métodos implícitos y explícitos (grupo intervención) o no  recibirlas (grupo control). Las variables primarias serán la proporción de  pacientes y el número medio de medicaciones potencialmente  inapropiadas por paciente. Las variables secundarias serán los recursos  asistenciales frecuentados, proporción de pacientes fallecidos y días de  supervivencia; y costes de medicamentos y de recursos asistenciales.Conclusiones: Análogamente a estudios similares, y en base al diseño de  nuestro estudio, esperamos obtener reducción estadísticamente  ignificativa para medicaciones potencialmente inapropiadas y costes de medicamentos. Sin embargo, no esperamos diferencias significativas en morbimortalidad ni en costes de recursos asistenciales.

Utility of a trigger tool (TRIGGER-CHRON) to detect adverse events associated with high-alert medications in patients with multimorbidity.

OBJECTIVE: To determine the utility of a tool (TRIGGER-CHRON) for identifying adverse drug events (ADEs) associated with the administration of high-alert medications in elderly patients with multimorbidity and to determine the medications most frequently implicated. METHODS: A retrospective observational study was conducted at 12 Spanish hospitals. A random sample of five medical records from each hospital was selected weekly for review over a 12-week period. We included patients aged 65 and over with multimorbidities, hospitalised for >48 hours. ADEs detected by the 32 TRIGGER-CHRON signals and caused by high-alert medications included on the Spanish HAMC list for chronic patients were selected for analysis. Triggers identified and ADEs detected were recorded. The severity and preventability of the ADEs were evaluated. The positive predictive value (PPV) of each trigger was calculated. RESULTS: On 720 charts reviewed, 908 positive triggers were identified that led to the detection of 158 ADEs caused by at least one high-alert medication on the HAMC list. These ADEs occurred in 139 patients (prevalence 19.3/100 admissions). The majority of ADEs were mild and 59.5% were deemed preventable. The drugs most frequently associated with ADEs were corticosteroids, loop diuretics, opioid analgesics and oral anticoagulants. Fifteen triggers had PPVs ≥20%. Six triggers (serum glucose >110 mg/dL, abrupt cessation of medication, oversedation/lethargy, hypotension, adverse reaction recorded and constipation) accounted for 69.8% of the ADEs identified. CONCLUSIONS: Applying the TRIGGER-CHRON to hospitalised patients with multimorbidity in 12 Spanish centres allowed detection of one adverse event caused by a high-alert drug for every four patients, which were preventable in a large proportion of patients. This confirms the need to establish interventions that reduce harm with these medications. We believe that TRIGGER-CHRON can be a useful tool to measure this harm and to determine the effects of medication safety improvement programmes as they are implemented.

[Development of integrated support software for clinical nutrition]. / Desarrollo de una aplicación informática de ayuda al soporte nutricional especializado integrado en la historia clínica electrónica.

OBJECTIVES: to develop an integrated computer software application for specialized nutritional support, integrated in the electronic clinical record, which detects automatically and early those undernourished patients or at risk of developing undernourishment, determining points of opportunity for improvement and evaluation of the results. METHODS: the quality standards published by the Nutrition Work Group of the Spanish Society of Hospital Pharmacy (SEFH) and the recommendations by the Pharmacy Group of the Spanish Society of Parenteral and Enteral Nutrition (SENPE) have been taken into account. According to these quality standards, the nutritional support has to include the following healthcare stages or sub-processes: nutritional screening, nutritional assessment, plan for nutritional care, prescription, preparation and administration. RESULTS: this software allows to conduct, in an automated way, a specific nutritional assessment for those patients with nutritional risk, implementing, if necessary, a nutritional treatment plan, conducting follow-up and traceability of outcomes derived from the implementation of improvement actions, and quantifying to what extent our practice is close to the established standard. CONCLUSIONS: this software allows to standardize the specialized nutritional support from a multidisciplinary point of view, introducing the concept of quality control per processes, and including patient as the main customer.

Objetivos: desarrollar una aplicacion informatica integral en el soporte nutricional especializado, e integrado en la historia clinica electronica, que detecte de forma automatizada y precoz a los pacientes desnutridos o en riesgo de desarrollar desnutricion, determinando puntos de oportunidad de mejora y evaluacion de resultados. Métodos: se han tenido en cuenta los estandares de calidad publicados por el grupo de trabajo de nutricion de la Sociedad Espanola de Farmacia Hospitalaria (SEFH) y las recomendaciones del grupo de farmacia de la Sociedad Espanola de Nutricion Parenteral y Enteral (SENPE). De acuerdo con dichos estandares de calidad, las etapas o subprocesos asistenciales que debe contemplar el soporte nutricional son: cribado nutricional, valoracion nutricional, plan de cuidados nutricionales, formulacion, elaboracion y administracion. Resultados: la aplicacion permite, de forma automatizada, realizar una valoracion nutricional especifica a los pacientes con riesgo nutricional, instaurando, si fuese preciso, un plan de tratamiento nutricional y realizando el seguimiento y trazabilidad de los resultados derivados de la implantacion de acciones de mejora y, cuantificando en que medida nuestra practica se aproxima a la establecida como estandar. Conclusiones: la aplicacion permite estandarizar el soporte nutricional especializado desde un punto multidisciplinar, introduciendo el concepto de control de calidad por procesos y al paciente como cliente principal.

Development of integrated support software for clinical nutrition / Desarrollo de una aplicación informática de ayuda al soporte nutricional especializado integrado en la historia clínica electrónica

Objectives: to develop an integrated computer software application for specialized nutritional support, integrated in the electronic clinical record, which detects automatically and early those undernourished patients or at risk of developing undernourishment, determining points of opportunity for improvement and evaluation of the results. Methods: the quality standards published by the Nutrition Work Group of the Spanish Society of Hospital Pharmacy (SEFH) and the recommendations by the Pharmacy Group of the Spanish Society of Parenteral and Enteral Nutrition (SENPE) have been taken into account. According to these quality standards, the nutritional support has to include the following healthcare stages or sub-processes: nutritional screening, nutritional assessment, plan for nutritional care, prescription, preparation and administration. Results: this software allows to conduct, in an automated way, a specific nutritional assessment for those patients with nutritional risk, implementing, if necessary, a nutritional treatment plan, conducting follow-up and traceability of outcomes derived from the implementation of improvement actions, and quantifying to what extent our practice is close to the established standard. Conclusions: this software allows to standardize the specialized nutritional support from a multidisciplinary point of view, introducing the concept of quality control per processes, and including patient as the main customer (AU)

Objetivos: desarrollar una aplicación informática integral en el soporte nutricional especializado, e integrado en la historia clínica electrónica, que detecte de forma automatizada y precoz a los pacientes desnutridos o en riesgo de desarrollar desnutrición, determinando puntos de oportunidad de mejora y evaluación de resultados. Métodos: se han tenido en cuenta los estándares de calidad publicados por el grupo de trabajo de nutrición de la Sociedad Española de Farmacia Hospitalaria (SEFH) y las recomendaciones del grupo de farmacia de la Sociedad Española de Nutrición Parenteral y Enteral (SENPE). De acuerdo con dichos estándares de calidad, las etapas o subprocesos asistenciales que debe contemplar el soporte nutricional son: cribado nutricional, valoración nutricional, plan de cuidados nutricionales, formulación, elaboración y administración. Resultados: la aplicación permite, de forma automatizada, realizar una valoración nutricional específica a los pacientes con riesgo nutricional, instaurando, si fuese preciso, un plan de tratamiento nutricional y realizando el seguimiento y trazabilidad de los resultados derivados de la implantación de acciones de mejora y, cuantificando en qué medida nuestra práctica se aproxima a la establecida como estándar. Conclusiones: la aplicación permite estandarizar el soporte nutricional especializado desde un punto multidisciplinar, introduciendo el concepto de control de calidad por procesos y al paciente como cliente principal (AU)