Off-label use of orphan medicinal products: a Belgian qualitative study

Abstract Background Off-label use of (orphan) medicinal products for (rare) diseases is quite common but not underpinned by clinical studies to confirm efficacy and safety. No risk-analyses by regulatory agencies are carried out. The objective of this study was to map off-label use of orphan medicinal products in Belgium in terms of attitude towards off-label prescribing, factors influencing off-label prescribing, disclosure of information towards the patient, reporting of off-label use, risks and consequences. Most of the EMA authorized orphan drugs are fully reimbursed in Belgium under well-... Mehr ...