title: Off-label prescription of drugs at hospital.
abstract: OBJECTIVE
  To develop a procedure for management of off-label medications, and to analyze the treatments, indications, and hospital units which will request them more frequently, as well as which variables will have an impact on the authorization decision, and its economic impact.
  
  
  METHODS
  A procedure was designed where clinicians would complete request forms and the Hospital Unit would prepare reports assessing their efficacy, safety, convenience, and cost. The request forms for the past five years were analyzed.
  
  
  RESULTS
  A total of 834 applications were received, and 88.1% of these were accepted. The authorization rates were higher for Paediatric Units (95.7% vs. 86.6%; p<0.05). The reasons for considering prescriptions as off-label were: different indication (73.2%), different combination (10.2%), different line of treatment (8.6%) and different age (8%). A 73.4% of requests were for antineoplastic drugs, and the most frequently prescribed were rituximab (120) and bevacizumab (103). The quality of evidence supporting the prescriptions was moderate-low, though no direct relationship with the likelihood of approval was demonstrated (p = 0.413). The cost of the approved medications was 8,567,537 €, and the theoretical savings for those drugs rejected was of 2,268,642 €. There was a statistically significant decrease in the authorization rate (p < 0.05, Student's t test) when spending increased.
  
  
  CONCLUSIONS
  The responsibility for assessing off-label prescriptions has fallen on the Pharmacy Unit. It has not been demonstrated that the quality of evidence represents a decisive variable for approval of treatment; on the other hand, age and cost have demonstrated a significant impact.
authors.affiliation: Pharmacy Unit, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia.. vicentearocas@hotmail.com.
authors.forename: Vicente
authors.initials: V
authors.lastname: Arocas Casañ
authors.affiliation: Pharmacy Unit, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia.. jaimewik@gmail.com.
authors.forename: Jaime
authors.initials: J
authors.lastname: Mateo Carmona
authors.affiliation: Pharmacy Unit, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia.. olga_gmolina@hotmail.com.
authors.forename: Olga
authors.initials: O
authors.lastname: García Molina
authors.affiliation: Pharmacy Unit, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia.. mafpe13@hotmail.com.
authors.forename: Ma Ángeles
authors.initials: MÁ
authors.lastname: Fernández de Palencia Espinosa
authors.affiliation: Pharmacy Unit, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia.. blazquez.mjose@gmail.com.
authors.forename: Ma José
authors.initials: MJ
authors.lastname: Blázquez Álvarez
authors.affiliation: Pharmacy Unit, Hospital Clínico Universitario Virgen de la Arrixaca, Murcia.. ameliadlrn@hotmail.com.
authors.forename: Ma Amelia
authors.initials: MA
authors.lastname: de la Rubia Nieto
authors.affiliation: Pharmacology Section, Universidad de Murcia.. jdelriog@um.es.
authors.forename: Jesús
authors.initials: J
authors.lastname: del Río García
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D011307:Drug Prescriptions / Q000592:standards*; D005260:Female; D006761:Hospitals; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008510:Medication Systems, Hospital; D008875:Middle Aged; D056687:Off-Label Use / Q000592:standards*; D010372:Pediatrics; D055815:Young Adult