[Medication: 15 years 'EU-directive orphan drugs']

The article describes the compounding, dispensing and reimbursement of orphan drugs in Belgium 15 years after the implementation of the EU Directive on orphan drugs. Despite the fact that they are life-threatening and free of charge, patient compliance to oral orphan medication seems to be a major problem that needs to be handled by the dispensing pharmacist. Parenteral orphan medication needs to be compounded in the hospital pharmacy following strict guidelines concerning handling and storage. For ultra-rare disorders the medication needs to be compounded using sometimes chemical grade ingredients without any pharmaceutical monograph. Cost-effectiveness will always remain a subject for debate.