[Assessment off-label prescribing in Dermatology].

INTRODUCTION

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.

PATIENTS AND 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.

DISCUSSION

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.