Pharmacovigilance & Drug Safety

Statement of the Problem: Off-label use is the intentional use of a drug outside the authorized product information. Within the European Union, a recent study revealed that a majority of published studies reporting levels of 20% or higher for the use of off-label medication and more than 55% when looking at the percentage of doctors prescribing off-label. Off-label use might be done due to unavailable authorized products for a specific age group (e.g. off label use in children) or therapeutic groups (e.g.anti-bacterial agents). In the latter, this has an impact on general public health in case of increase in resistance. Off-label use has to be collected by MAHs for further assessment and evaluation. Normally the MAH receives information about off-label use when additional adverse drug reactions happened or via medical enquiries by the treating physicians. The MAHs inform then the reporting physician about the off-label use. Normally, no further data are directly provided by the physician leading to an under-reporting of off-label use and therefore, a lack of appropriate analyzing possibilities and corrective action-taking.Methodology & Theoretical Orientation: In the European database of adverse drug reaction reports the total number of reported cases and the number of reported off-label use was analysed for seven antibiotics. The data include all reports up to

March 2017. Based on feedback from physicians via interviews, nearly 50% prescribed antibiotics off-label.Conclusion & Significance: There is an under-reporting of off-label use in regards to what physicians are reporting on interviews and reporting as cases. This is leading to data of poor quality and evaluability. The analysis process of off-label use should therefore be adopted to reflect the current situation which might lead to a better use of knowledge and current treatment methods of physicians.