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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

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. 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.

Keywords

China Neurological patients Observational Off-label prescribing Retrospective Supporting evidence 

Notes

Acknowledgments

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.

Funding

None.

Conflicts of interest

The authors declare no conflict of interest.

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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

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