Aim: To evaluate the reason off-label use exists in paediatric general practice and to distinguish between non-compliance with respect to regulatory standards and non-compliance with respect to guidelines in order to determine what this difference means in terms of rational prescribing.
Methods: Information on patients visited by 35 general paediatricians in southern Italy was collected and their prescriptions analysed for off-label status. Off-label drug use in the Italian paediatric community setting was assessed. A sample indication, pharyngotonsillitis, was chosen and the related prescriptions analysed, distinguishing between non-compliance with regulatory standards (i.e. off-label use) and non-compliance with guidelines, in order to determine the appropriateness of prescribing.
Results: Information was collected on 9917 patients (8476 prescriptions). In all, 17% of prescriptions were off label. When the 1675 pharyngotonsillitis prescriptions were analysed, 8% were off label and 63% were not in accordance with the guidelines. On the other hand, 55% of these prescriptions did not adhere to the guidelines, but were not off label either.
Conclusion: The results of this study were surprising because off-label drug use for pharyngotonsillitis, a common paediatric condition, was low, while non-adherence to guidelines was high. In cases such as this one, in which guidelines exist, physicians' prescribing habits were irrational because they did not follow the evidence. Physicians should keep up to date with new knowledge and should be provided with updated product information.