PHP337 - OFF-LABEL PRESCRIPTION OF DRUGS COMPARED TO PRESCRIPTION AFTER LABEL EXTENSION IN CHILDREN FOR GERMANY

Abstract

In Germany off-label prescription of drugs is very common in pediatrics since about 30 % of drugs is not authorized for use in children. In 1990 a precedent case determined that drugs should be prescribed according to the international state of knowledge and not according to the authorized therapeutic indication. However, health insurances are not obliged to reimburse such prescriptions and manufacturers are not liable for adverse events. This leaves doctors in an uncertain situation regarding regresses and liabilities. Therefore, it was assessed if authorization influences their prescription behavior. In order to evaluate a probable increase in pediatric prescriptions of drugs after a label extension or a pediatric-use market authorization (PUMA) for use in children a number of drugs were identified which had been authorized for at least 3 years before the label extension for children and with a minimum follow up period of one year. The IQVIA Disease Analyzer was used to identify the number of prescriptions before and after the label extension or PUMA. In total 2 PUMA drugs and 1 patented drug could be identified for further analysis. The number of prescription for Midazolam (epilepsy) and Propranolol (proliferating infantile haemangioma), both PUMA, increased after marketing authorization. In contrast, Zonisamid (epilepsy) remained on the same prescription level. PUMA seems to influence prescription behavior positively. However, the results are limited by a low overall number of prescriptions due to rare diseases in children. Further studies about off label prescription in adults would enhance our understanding of this issue.