ABSTRACT
OBJETIVO: Analizar el impacto de una estrategia de adecuación de ranelato de estroncio tras la emisión de recomendaciones, en base a las notas de farmacovigilancia emitidas por la Agencia Española de Medicamentos y Productos Sanitarios, así como el grado de aceptación. DISEÑO: Estudio prospectivo de intervención desde abril de 2012 a noviembre de 2014. Emplazamiento: Área de Gestión Sanitaria Sur de Sevilla. PARTICIPANTES: Pacientes con prescripción activa de ranelato de estroncio. INTERVENCIONES: Se realizó en cuatro fases, ligada a la emisión de notas de farmacovigilancia sobre ranelato de estroncio por la Agencia Española de Medicamentos y Productos Sanitarios, listados de pacientes y recomendaciones de adecuación. MEDICIONES PRINCIPALES: Adecuación del tratamiento con ranelato de estroncio y grado de aceptación de las recomendaciones por los facultativos. RESULTADOS: Desde el inicio del estudio, con 182 pacientes incluidos, hasta el comienzo de la revisión de la adecuación por farmacia, se produjo una reducción del 87,9%. La prescripción de ranelato de estroncio era inadecuada en 16 pacientes de los 22; 11 por no cumplir criterios de tratamiento, tres por no haber tenido tratamiento previo con otros medicamentos para prevención de fracturas y dos por contraindicación. El grado de aceptación de las recomendaciones fue del 87,5%, produciéndose en diez pacientes la suspensión de ranelato de estroncio y en cuatro, el cambio a alendrónico o alendrónico/colecalciferol. CONCLUSIONES: El número de pacientes con prescripción de ranelato de estroncio ha disminuido considerablemente. Las intervenciones dirigidas a la revisión de la adecuación del tratamiento, en base a las alertas de farmacovigilancia han sido efectivas
OBJECTIVE: To analyse the impact of a strategy on the suitability of strontium ranelate, and its level of acceptance, after issuing recommendations based on drug surveillance alerts issued by the Spanish Medicines and Medical Devices Agency. DESIGN: A prospective interventional study conducted from April 2012 to November 2014. SETTING: South Seville Health Management Area. PARTICIPANTS: Patients currently prescribed with strontium ranelate. INTERVENTIONS: The study consisted of four phases linked to the issue of drug surveillance alerts on strontium ranelate by the Spanish Medicines and Medical Devices Agency, listed by patients and suitability recommendations. MAIN MEASUREMENTS: Suitability of strontium ranelate treatment and the level of acceptance by physicians. RESULTS: There was a reduction of 87.9% in prescriptions from the beginning of the study, with 182 patients included, until the review of the suitability of the drug began. The prescribing of strontium ranelate was unsuitable in 16 out of the 22 patients remaining; 11 of which were due not meeting the treatment criteria, 3 for not having had previous treatments with other drugs for the prevention of fractures, and 2 due to contraindications. The level of acceptance of the recommendations was 87.5%, leading to the stopping of strontium ranelate in 10 patients, and the changing to alendronate or alendronate/cholecalciferol in another four PATIENTS: CONCLUSIONS: The number of patients prescribed strontium ranelate has decreased considerably. The interventions directed at reviewing the suitability of this treatment, based on the drug surveillance alerts, have been effective
Subject(s)
Humans , Male , Female , Strontium/therapeutic use , Pharmacovigilance , Sanitary Management/methods , Sanitary Management/statistics & numerical data , Sanitary Management/standards , Drug Monitoring/methods , Drug Monitoring/standards , Drug and Narcotic Control/methods , Drug and Narcotic Control/organization & administration , Drug Evaluation/standards , Prospective StudiesABSTRACT
OBJECTIVE: To analyse the impact of a strategy on the suitability of strontium ranelate, and its level of acceptance, after issuing recommendations based on drug surveillance alerts issued by the Spanish Medicines and Medical Devices Agency. DESIGN: A prospective interventional study conducted from April 2012 to November 2014. SETTING: South Seville Health Management Area. PARTICIPANTS: Patients currently prescribed with strontium ranelate. INTERVENTIONS: The study consisted of four phases linked to the issue of drug surveillance alerts on strontium ranelate by the Spanish Medicines and Medical Devices Agency, listed by patients and suitability recommendations. MAIN MEASUREMENTS: Suitability of strontium ranelate treatment and the level of acceptance by physicians. RESULTS: There was a reduction of 87.9% in prescriptions from the beginning of the study, with 182 patients included, until the review of the suitability of the drug began. The prescribing of strontium ranelate was unsuitable in 16 out of the 22 patients remaining; 11 of which were due not meeting the treatment criteria, 3 for not having had previous treatments with other drugs for the prevention of fractures, and 2 due to contraindications. The level of acceptance of the recommendations was 87.5%, leading to the stopping of strontium ranelate in 10 patients, and the changing to alendronate or alendronate/cholecalciferol in another four patients. CONCLUSIONS: The number of patients prescribed strontium ranelate has decreased considerably. The interventions directed at reviewing the suitability of this treatment, based on the drug surveillance alerts, have been effective.
