Off-label prescribing in the treatment of dermatologic disease.
BACKGROUND
It is common practice for physicians to treat dermatologic conditions with medications that are not indicated for the specific condition being treated. These "off-label" prescriptions are often for medications that have both well accepted therapeutic value in the medical community and proven efficacy on the basis of results of clinical trials.


OBJECTIVE
Our purpose was to quantify the use of off-label prescriptions for dermatologic disease by a representative sample of physicians in the United States.


METHODS
Data from the 1990-1997 National Ambulatory Medical Care Survey, performed by the National Center for Health Statistics, were used to assess medications prescribed at office visits for dermatologic disease. We identified the most common diagnoses listed at office visits in which the primary and only diagnosis listed was dermatologic. For the leading 10 dermatologic conditions for which medications are indicated, we categorized each primary drug mention by indication.


RESULTS
We found that the range of off-label prescribing varied from 17% to 73%, with a weighted mean (+/- SD) of 32% +/- 18%. The conditions most frequently managed with off-label prescriptions were acne rosacea (73%) and actinic keratosis (52%), whereas those with the fewest off-label prescriptions were atopic dermatitis (17%) and psoriasis (16%). The use of off-label prescriptions by dermatologists in the diseases studied ranged from 7% to 73% with a weighted mean (+/- SD) of 24% (+/- 24%), whereas the range for nondermatologists was 18% to 96% with a weighted mean (+/- SD) of 34% (+/- 18%).


CONCLUSIONS
Off-label prescribing is common in the management of dermatologic conditions. From these data, we conclude that it is currently within the standard of care to use off-label prescriptions in the treatment of dermatologic disease.
Sugarman
Joel H
JH
Bristol Myers-Squibb Center for Dermatology Research and the Department of Dermatology Wake Forest University School of Medicine, Winston-Salem, NC 27157-1071, USA.
Fleischer
Alan B
AB
Feldman
Steven R
SR
D004348:Drug Labeling; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D019538:Health Care Surveys; D006801:Humans; D007349:Insurance, Health, Reimbursement; D009819:Office Visits / Q000706:statistics & numerical data; D010818:Practice Patterns, Physicians' / Q000191:economics / Q000706:statistics & numerical data*; D012393:Rosacea / Q000188:drug therapy; D012871:Skin Diseases / Q000188:drug therapy*; D014481:United States