RESUMO
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)
Assuntos
Humanos , Masculino , Feminino , Idoso , Idoso de 80 Anos ou mais , Prescrições de Medicamentos , Atenção Primária à Saúde , Prescrição Inadequada/prevenção & controle , Polimedicação , Lista de Medicamentos Potencialmente Inapropriados , Centros de Saúde , Farmacêuticos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Prospectivos , Morbidade , MortalidadeRESUMO
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.
Assuntos
Polimedicação , Lista de Medicamentos Potencialmente Inapropriados , Idoso , Humanos , Prescrição Inadequada/prevenção & controle , Prescrições , Atenção Primária à Saúde , Estudos ProspectivosRESUMO
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)
