Over-the-counter (OTC) drug regulation and the epidemiology of OTC drug use in Germany

Abstract

Introduction: Public health practice must ensure efficient access to effective and safe pharmaceuticals, while protecting the population from health risks related to the inappropriate use of pharmaceuticals. Background: About half of all packs sold in German pharmacies are over-the counter (OTC) drugs; their use and regulation is thus a subject of high relevance to public health. At the same time, OTC drugs receive rather limited attention in the drug regulatory and pharmacological literature, and little empirical evidence is available about OTC drug consumption and risk perceptions. Scope: The present thesis is based on four individual research papers that cover perceptions of and behaviours regarding OTC drugs among German adults, reasons for unsuccessful applications for changes to drug trade statuses, pharmacological perspectives on prescription-only (Rx)-to-OTC switches and the prevalence and predictors of OTC drugs use. Methods: This research draws on mixed methods, including an online survey, qualitative content analysis of policy and legislative documents and epidemiological analysis of data from the first phase of the German Health Interview and Examination Survey for Adults. Results: Among the adult population living in Germany, a seven-day OTC drug use prevalence of 40.2% was found. Female gender, older age, self-reported reduced health status and multimorbidity were significant predictors of OTC drug use. There were seven Rx-to-OTC switches between 2006 and 2015, but not all of these decisions were fully in line with the recommendations of the EU guideline on changing drug trade statuses. Further, unsuccessful applications for Rx-to-OTC switches, OTC-to-Rx switches and other changes trade Status were not infrequent. At the expert level, the most important reasons for rejected applications were drug safety concerns and insufficient data. At the policy level, negative decisions were mainly made because of legal restrictions. It was also found that risk perception of OTC drugs greatly depends on the route of administration and whether the product is plant-based or not. Moreover, consumers do not always read all details in the package leaflet. Conclusions: This thesis constitutes the first measure of OTC drug use in a representative sample of the adult population living in Germany. With a seven-day prevalence of 40.2%, OTC drug use is significant. While applications for changes in drug trade status and their fate are transparent, the reasons for negative recommendations are far less traceable. The findings of this thesis have led to the identification of several opportunities to improve OTC drug regulation. Detailed justifications for negative decisions on applications to changing drug trade statuses should be provided. Data that are already available a for instance, from large epidemiological studies a could be used to inform decision-making on potential changes to drug trade statuses. Such studies should make a distinction between self-medication and OTC drug use; they should also collect information on the doses and durations of OTC drug use. In addition, past changes to trade statuses should be evaluated so that lessons learned can inform future decision-making. Elaboration of a set of criteria concerning the risks and benefits of OTC availability is also recommended to increase evidence-based OTC drug regulation.