International Journal of Clinical Pharmacy

, Volume 34, Issue 1, pp 81–87 | Cite as

Off-label prescriptions for adult neurological patients: a pilot survey in China

  • Zhan-Miao Yi
  • Suo-Di Zhai
  • Sen Huang
  • Tian-Sheng Wang
  • Fang LiuEmail author
Research Article


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. Setting Single, 1,264-bed, tertiary care university hospital in Beijing, China. Method 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. Main outcome measure 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.


China Neurological patients Observational Off-label prescribing Retrospective Supporting evidence 



We thank Jue Gong, Yan Liang and Xin Zhang from Peking University Health Science Center for help with data extraction. We also feel grateful for Emily C. Lau and Sherry Liu from University of Connecticut for help with editing.



Conflicts of interest

The authors declare no conflict of interest.


  1. 1.
    American Society of Hospital Pharmacists. ASHP statement on the use of medications for unlabeled uses. Am J Hosp Pharm. 1992;49(8):2006–8.Google Scholar
  2. 2.
    Ventola CL. Off-label drug information: regulation, distribution, evaluation, and related controversies. Pharm Ther. 2009;34(8):428–40.Google Scholar
  3. 3.
    O’Reilly J, Dalal A. Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs. Ann Health Law. 2003;12(2):295–324.PubMedGoogle Scholar
  4. 4.
    Neubert A, Dormann H, Weiss J, Egger T, Criegee-Rieck M, Rascher W, et al. The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Saf. 2004;27(13):1059–67.PubMedCrossRefGoogle Scholar
  5. 5.
    Herring C, McManus A, Weeks A. Off-label prescribing during pregnancy in the UK: an analysis of 18 000 prescriptions in Liverpool women’s hospital. Int J Pharm Pract. 2010;18(4):226–9.PubMedGoogle Scholar
  6. 6.
    Bell SG. Off-label medication use in the NICU. Neonatal Netw. 2010;29(4):253–5.PubMedCrossRefGoogle Scholar
  7. 7.
    Phan H, Leder M, Fishley M, Moeller M, Nahata M. Off-label and unlicensed medication use and associated adverse drug events in a pediatric emergency department. Pediatr Emerg Care. 2010;26(6):424–30.PubMedCrossRefGoogle Scholar
  8. 8.
    Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166(9):1021–6.PubMedCrossRefGoogle Scholar
  9. 9.
    Lat I, Micek S, Janzen J, Cohen H, Olsen K, Haas C. Off-label medication use in adult critical care patients. J Crit Care. 2011;26(1):89–94.PubMedCrossRefGoogle Scholar
  10. 10.
    Abernethy AP, Raman G, Balk EM, Hammond JM, Orlando LA, Wheeler JL, et al. Systematic review: reliability of compendia methods for off-label oncology indications. Ann Intern Med. 2009;150(5):336–43.PubMedGoogle Scholar
  11. 11.
    Oxford Center for Evidence-based Medicine. Levels of evidence. Oxford, UK [updated 2011 April; cited 31 Jul 2010]. Available from:
  12. 12.
    Cras A, Conscience MA, Rajzbaum G, Lillo-Le Louët A, Lopez N, Tersen I, et al. Off-label prescribing in a French hospital. Pharm World Sci. 2007;29(2):97–100.PubMedCrossRefGoogle Scholar
  13. 13.
    Heidrich H, Gerke E, Nekarda H. Thrombozytenaggregationshemmung unter Calciumdobesilat. Arzneimittelforschung. 1983;33:580–2.PubMedGoogle Scholar
  14. 14.
    Nagakawa Y, Akedo Y, Kaku S. Effect of nicergoline on platelet aggregation, plasma viscosity and erythrocyte deformability in geriatric patients with cerebral infarction preliminary report. Arzneimittelforschung. 1990;40(8):862–4.PubMedGoogle Scholar
  15. 15.
    Zhou Shaohua. Intervention of mecobalamin homocysteine in stroke patients. J Pract Med. 2007;23(11):1757.Google Scholar
  16. 16.
    Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf. 2006;5(5):703–18.PubMedCrossRefGoogle Scholar
  17. 17.
    Ekins-Daukes S, Helms PJ, Simpson CR, Taylor MW, McLay JS. Off-label prescribing to children in primary care: retrospective observational study. Eur J Clin Pharmacol. 2004;60(5):349–53.PubMedCrossRefGoogle Scholar
  18. 18.
    Bazzano AT, Mangione-Smith R, Schonlau M, Suttorp MJ, Brook RH, et al. Off-label prescribing to children in the United States outpatient setting. Acad Pediatr. 2009;9(2):81–8.PubMedCrossRefGoogle Scholar
  19. 19.
    Toscani F, Di Giulio P, Campi R, Pellerin I, De Luca A, Casale G, et al. Off-label prescriptions in Italian hospices: a national survey. J Pain Symptom Manag. 2009;38(3):365–71.CrossRefGoogle Scholar
  20. 20.
    Martin-Latry K, Ricard C, Verdoux H. A 1-day survey of characteristics of off-label hospital prescription of psychotropic drugs. Pharmacopsychiatry. 2007;40(3):116–20.PubMedCrossRefGoogle Scholar
  21. 21.
    Infante Pina D, Badia Llach X, Ariño-Armengol B, Villegas Iglesias V. Prevalence and dietetic management of mild gastrointestinal disorders in milk-fed infants. World J Gastroenterol. 2008;14(2):248–54.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media B.V. 2011

Authors and Affiliations

  • Zhan-Miao Yi
    • 1
  • Suo-Di Zhai
    • 1
  • Sen Huang
    • 2
  • Tian-Sheng Wang
    • 3
  • Fang Liu
    • 1
    Email author
  1. 1.Department of PharmacyPeking University Third HospitalBeijingChina
  2. 2.Department of Health Policy and Management, School of Public HealthPeking UniversityBeijingChina
  3. 3.Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical SciencePeking UniversityBeijingChina

Personalised recommendations