Adecuación de ranelato de estroncio tras alertas de farmacovigilancia en un área de gestión sanitaria / Suitability of strontium ranelate in a health care management area after drug surveillance alert

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

[Suitability of strontium ranelate in a health care management area after drug surveillance alerts]. / Adecuación de ranelato de estroncio tras alertas de farmacovigilancia en un área de gestión sanitaria.

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.

Influence of adding etravirine on complexity index and patients' perceived complexity.

WHAT IS KNOWN AND OBJECTIVE: Adherence to highly active antiretroviral treatment (HAART) is an important predictive factor of treatment outcome. Medication regimen complexity can be one of the main causes of non-adherence. Thus, treatment simplification is a key strategy in the development of antiretroviral therapy. The aim of this study was to determine the influence of adding etravirine on complexity index and patients' perceived complexity of their treatment regimen. METHODS: We conducted a prospective two-centre observational study. Patients on etravirine-based therapy, for at least 6 months, who came personally to pharmacy departments for a drug refill from February to July 2012 were included. Data were collected for the current etravirine-based HAART and for the previous HAART without etravirine. The main variables were complexity index and patients' perceived complexity. We also evaluated the adherence during the 6 months before and after the introduction of etravirine into HAART. The complexity index was based on a score which takes into account the number of pills per day, the dosing schedule, the dosage form and any specific instructions linked to use of the drug. To evaluate the patients' perceived complexity of their current and previous HAART, patients were asked to assign a mark on a visual analogue scale ranging from 0 (minimum) to 10 (maximum). We assessed the differences in the variables collected between the current and previous antiretroviral therapy. Finally, we carried out a correlation analysis between the complexity index and the patients' perceived complexity. RESULTS AND DISCUSSION: Eighty patients were included. The complexity index was significantly reduced after the addition of etravirine to HAART (P = 0·035). Perceived complexity was also reduced (P = 0·015). After the introduction of the drug, the proportion of adherent patients increased from 65% to 81·3% (P = 0·002). The correlation between the complexity index and the patients' perceived complexity was positive (r = 0·594). The correlation increased (r = 0·696) when the difference between the complexity index before and after the introduction of etravirine in HAART grew. WHAT IS NEW AND CONCLUSION: The addition of etravirine to HAART results in a significant reduction in complexity index and patients' perceived complexity of their therapy. These changes were associated with better adherence to treatment.