Maciá Martínez Miguel-Ángel
División de Farmacoepidemiología y Farmacovigilancia, Departamento de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, Ministerio de Sanidad, Servicios Sociales e Igualdad, Madrid, España.
Reumatol Clin. 2015 Nov-Dec;11(6):345-52. doi: 10.1016/j.reuma.2014.12.003. Epub 2015 Jan 28.
A retrospective economic evaluation was performed on the restriction of the use of piroxicam in Spain, a non-steroidal anti-inflammatory drug, with a proven higher risk of serious gastrointestinal complications compared to other non-steroidal anti-inflammatory drugs with the objective of putting the relevance of these activities into context.
A retrospective cost-effectiveness analysis and a budget impact analysis were performed. Costs and cases of serious gastrointestinal complications were compared in the non-intervention (use of piroxicam) and the intervention scenarios (use of other non-steroidal anti-inflammatory drugs). The cost of serious gastrointestinal complications was obtained from the Diagnosis Related Groups and the cost of non-steroidal anti-inflammatory drugs from usage data in the Spanish national health system. The risk of serious gastrointestinal complications was obtained from epidemiological studies.
The regulatory intervention was the dominant option. In that sense, 0.81 euros per treated patient were saved, 2.75 cases of serious gastrointestinal complications were avoided per 10,000 patients and 578,608 euros were saved in total in Spain in the first year following the intervention.
It is possible to perform complete economical evaluations on pharmacovigilance actions. The intervention performed by the Spanish Agency for Medicines and Medical Devices, AEMPS on piroxicam not only achieved the objective of preventing adverse drug reactions but also resulted in significant economical savings even under conservative assumptions.
对西班牙限制使用吡罗昔康（一种非甾体抗炎药）进行回顾性经济评估，与其他非甾体抗炎药相比，已证实该药有更高的严重胃肠道并发症风险，目的是将这些活动的相关性置于背景中。
进行回顾性成本效益分析和预算影响分析。比较了非干预（使用吡罗昔康）和干预情景（使用其他非甾体抗炎药）下严重胃肠道并发症的成本和病例数。严重胃肠道并发症的成本来自诊断相关组，非甾体抗炎药的成本来自西班牙国家卫生系统的使用数据。严重胃肠道并发症的风险来自流行病学研究。
监管干预是主要选择。从这个意义上说，每位接受治疗的患者节省了0.81欧元，每10000名患者避免了2.75例严重胃肠道并发症，干预后的第一年西班牙总共节省了578608欧元。
有可能对药物警戒行动进行全面的经济评估。西班牙药品和医疗器械管理局（AEMPS）对吡罗昔康采取的干预措施不仅实现了预防药物不良反应的目标，而且即使在保守假设下也带来了显著的经济节省。
