Routinedatenbasierte Untersuchungen zum Off-Label-Use in der ambulanten Versorgung

Abstract

In many medical disciplines, particularly in paediatrics, psychiatry and oncology, drugs are often prescribed off-label. An off-label use is defined as the practice of prescribing drugs outside the terms of the product license, especially prescribed for an unapproved indication or age group. One problem is the impact of off-label use on drug safety in terms of adverse drug reactions associated with these drugs. In Germany, only limited data investigating the extent of off-label use in ambulatory care exist. Over the years, the use of secondary data from large administrative healthcare databases for pharmacoepidemiological and health service research increased. Drug utilisation studies based on these population-based data are valuable to explore patterns of drug use including off-label use. This thesis investigates the ambulatory off-label use of antidepressant and antiepileptic drugs in paediatric patients and the ambulatory off-label use of lenalidomide in oncology patients based on claims data of statutory health insurances. Drug utilisation studies to evaluate off-label use are closing a gap in the ascertainment of drug safety after approval. As physician's prescription behaviour is not influenced, claims data of statutory health insurances are an important data source to study off-label use, particularly in patients that are often underrepresented in clinical trials.