title: Off-label prescriptions for adult neurological patients: a pilot survey in China.
abstract: BACKGROUND
  Data concerning the extent of off-label prescriptions for adult neurological patients are limited, and the method of assessing supporting evidence in previous studies has some limitations.
  
  
  OBJECTIVE
  To improve the method of assessing supporting evidence, determine the status of off-label prescriptions for adult neurological patients, and evaluate the varying levels of supporting evidence.
  
  
  METHODS
  Single, 1,264-bed, tertiary care university hospital in Beijing, China.
  
  
  METHODS
  This was a pilot retrospective observational study for adult neurological patients during the period of March 22nd-28th, 2010. Off-label prescriptions were defined according to package inserts. The DRUGDEX system was used to evaluate supporting evidence initially; when information was not available, PubMed/CBM was searched and the grading system proposed by Oxford Centre for Evidence-Based Medicine (OCEBM) was used for categorizing supporting evidence alternatively.
  
  
  METHODS
  Types, main therapeutic classes and main neurological diseases involved, evidence and recommendation strengths of off-label prescriptions.
  
  
  RESULTS
  A total of 418 off-label prescriptions were identified from 3,187 prescriptions for 966 patients, 193 from 759 inpatient (25.4%) and 225 from 2,428 outpatient care (9.3%). Most off-label prescriptions were related to unapproved indications. These off-label prescriptions mainly included drugs labeled for nervous system diseases, cerebrovascular diseases, anemia and ophthalmic conditions; and the medication orders were mostly for cerebrovascular diseases. A total of 155 (37.1%) were initially searched and evaluated in the DRUGDEX system; the remaining 263 (62.9%) prescriptions were found in PubMed/CBM search and evaluated by the OCEBM grading system. Sixty-six (34.2%) off-label prescriptions from inpatients and 103 (45.8%) from outpatients were categorized as Class III or Grade D recommendations.
  
  
  CONCLUSIONS
  The improved method provided a supplementary way to study off-label uses. Off-label prescriptions for adult neurological patients mainly concerned unapproved indications, nervous system agents and cerebrovascular diseases, and many of them had inferior level of evidence.
authors.affiliation: Department of Pharmacy, Peking University Third Hospital, Beijing, China.
authors.forename: Zhan-Miao
authors.initials: ZM
authors.lastname: Yi
authors.forename: Suo-Di
authors.initials: SD
authors.lastname: Zhai
authors.forename: Sen
authors.initials: S
authors.lastname: Huang
authors.forename: Tian-Sheng
authors.initials: TS
authors.lastname: Wang
authors.forename: Fang
authors.initials: F
authors.lastname: Liu
mesh_terms: D000368:Aged; D002681:China; D003625:Data Collection; D016208:Databases, Factual; D019317:Evidence-Based Medicine; D005260:Female; D006785:Hospitals, University; D006801:Humans; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000188:drug therapy*; D056687:Off-Label Use; D010865:Pilot Projects; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D012189:Retrospective Studies