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Related Experiment Videos

Off-label prescribing among office-based physicians.

David C Radley1, Stan N Finkelstein, Randall S Stafford

  • 1Center for Evaluative Clinical Sciences, Dartmouth Medical School, Hanover, NH, USA.

Archives of Internal Medicine
|May 10, 2006
PubMed
Summary
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Off-label drug use is common, accounting for 21% of prescriptions in 2001. Most of these uses lacked scientific evidence, raising concerns for patient safety and healthcare costs.

Area of Science:

  • Pharmacology
  • Health Services Research
  • Drug Utilization

Background:

  • Off-label drug use, prescribing medications for unapproved indications, often lacks rigorous scientific evaluation.
  • Concerns exist regarding patient safety and healthcare system costs associated with off-label prescribing.
  • Limited data are available on the prevalence and scientific basis of off-label medication use.

Purpose of the Study:

  • To determine the frequency of off-label drug use in outpatient settings.
  • To assess the level of scientific evidence supporting identified off-label uses.
  • To identify characteristics of drugs and patient populations associated with increased off-label prescribing.

Main Methods:

  • Utilized nationally representative data from the 2001 IMS Health National Disease and Therapeutic Index (NDTI).

Related Experiment Videos

  • Analyzed prescribing patterns for 160 common drugs, categorizing each drug-diagnosis combination as Food and Drug Administration-approved or off-label (with varying levels of scientific support).
  • Employed multivariate analyses to identify predictors of off-label use.

    • Main Results:

    • An estimated 150 million (21%) off-label medication uses occurred in 2001.
    • Off-label prescribing was most prevalent for cardiac medications (46%) and anticonvulsants (46%).
    • The majority of off-label uses (73%) had limited or no scientific support; gabapentin and amitriptyline hydrochloride showed high proportions of off-label use.

    Conclusions:

    • Off-label medication use is a widespread practice in outpatient care.
    • Most off-label prescriptions are not supported by robust scientific evidence.
    • There is a need to evaluate and address off-label prescribing that may impact patient safety and lead to inefficient healthcare spending.