title: Economic evaluation of the restriction in the use piroxicam in Spain.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: 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. Electronic address: mmacia@aemps.es.
authors: Miguel-Ángel
authors: MÁ
authors: Maciá Martínez
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000191:economics*; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D004335:Drug and Narcotic Control / Q000191:economics*; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000191:economics* / Q000517:prevention & control*; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D018803:Models, Economic; D010894:Piroxicam / Q000009:adverse effects* / Q000191:economics*; D012189:Retrospective Studies; D018570:Risk Assessment; D013030:Spain
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010894:Piroxicam
keywords: Anti-inflammatory agents, non-steroidal; Antiinflamatorios no esteroideos; Análisis coste-beneficio; Cost-benefit analysis; Costos y análisis de coste; Costs and cost analysis; Drug-related side effects and adverse reactions; Efectos colaterales y reacciones adversas relacionados con medicamentos; España; Farmacovigilancia; Gastrointestinal haemorrhage; Hemorragia gastrointestinal; Pharmacovigilance; Piroxicam; Spain