Unsuccessful applications to increase or decrease the over-the-counter (OTC) availability of drugs in Germany between 2009 and 2014

Abstract

To provide an overview of applications to change drug prescription status submitted to the German Federal Institute for Drugs and Medical Devices between 2009 and 2014 and to examine the success of these applications based on regulatory considerations. A content analysis of session minutes held by the Expert Advisory Committee for Prescription-Only Issues (EAC) which provides independent advice on questions of mandatory prescription to the German Ministry of Health was conducted. Additionally, changes to the Ordinance on Prescription-Only Medicinal Products were analysed. In total, there were 101 applications, 91 of which concerned non-alternative medicines for human use. The latter regarded 38 increases in over-the-counter (OTC) availability, 46 decreases in OTC availability and seven legally insignificant changes of wording. The EAC recommended rejecting 13 applications for increased OTC availability. Common reasons were substances’ insufficient OTC suitability, such as inappropriate indications or the risk of delaying diagnosis of serious disease, followed by insufficient data quality of applications. Reasons for not recommending a decrease in OTC availability were that Rx status would probably not improve early detection of disease complications, that the risk of abuse of the respective OTC drug was low, and that pack size restrictions of OTC drugs may not improve patient compliance regarding restricted duration of use. These decisions also considered the public health benefits of a substance’s OTC availability. Insufficient data relevant to self-medication remains a common challenge for regulators. Further research on drug utilisation in the OTC setting and its implications for regulatory decisions is necessary.