Assessment off-label prescribing in Dermatology

Background: The official policy of the French National Health Insurance system is to deny reimbursement for drugs prescribed for off-label indications. The objectives of this study were 1) to quantify the use of off-label prescriptions by physicians from a hospital department of dermatology in France; 2) to characterize these off-label prescriptions; 3) to assess data from the literature on the appropriateness of these off-label prescriptions.

Methods: For each patient consulting between February 1 and April 1, 2001, the symptom or the disease that was treated and the type of prescription were recorded on standard forms.

Results: Eighty six percent of prescriptions were labelled, 14 p. 100 were off-labelled. Inflammatory and hypersensitivity dermatoses were the most frequent indications of off-label prescriptions (26 p. 100). Treatments which most frequently corresponded to off-label prescriptions were topical corticosteroids and methotrexate. Examination of the literature showed that 70 p. 100 of the off-label prescriptions were not based on strong data from evidence-based-medicine. Many off-label prescriptions were made by the most graduate physicians.

Conclusions: This study showed a great number of off-label prescriptions in dermatology. These prescriptions were often related to rare diseases that were managed by senior dermatologists. These off-label prescriptions were rarely in accordance with data from evidence-based-medicine.