[Suitability of strontium ranelate in a health care management area after drug surveillance alerts]

[药物监测警报后,雷奈酸锶在医疗保健管理领域的适用性]

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Abstract

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.

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