title: From prescription-only (Rx) to over-the-counter (OTC) status in Germany 2006-2015: pharmacological perspectives on regulatory decisions.
abstract: OBJECTIVE
  Little is known about the extent of switches from prescription-only (Rx) to over-the-counter (OTC) status in Europe and about the pharmacological properties of the switched substances. The objectives of this study were to provide an overview of the substances that were switched from Rx to OTC status in Germany between 2006 and 2015 and to assess their pharmacological properties.
  
  
  METHODS
  Session minutes of the German Expert Advisory Committee for Prescription-Only Issues, changes to the German Ordinance on Prescription-Only Medicines and the Summary of Product Characteristics of the switched substances were analysed. Pharmacological properties were studied in relation to the EU Guideline on Changing the Classification for the Supply of a Medicinal Product for Human Use (the 'EU switch guide').
  
  
  RESULTS
  Between 2006 and 2015, seven substances (almotriptan, omeprazole, benzydamine, ibuprofen/pseudoephedrine, racecadotril, ketotifen and levonorgestrel) were switched from Rx to OTC status in Germany. In all cases, the OTC status was restricted to certain indications, doses, pack sizes, or other limitations. Notwithstanding recommendations of the EU switch guide, some of the switched substances might interact with commonly used drugs potentially resulting in serious adverse drug reactions or have contraindications or warnings regarding substantial parts of the population.
  
  
  CONCLUSIONS
  The stipulations of the EU switch guide were fully met for only some switches, while this was not completely the case for others. Further development of guidance on balancing risks and benefits of OTC availability is recommended.
authors.affiliation: Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstraße 30, 28359, Bremen, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Barrenberg
authors.affiliation: Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Achterstraße 30, 28359, Bremen, Germany. garbe@uni-bremen.de.|Core Scientific Area 'Health Sciences', University of Bremen, Bremen, Germany. garbe@uni-bremen.de.
authors.forename: Edeltraut
authors.initials: E
authors.lastname: Garbe
mesh_terms: D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D005858:Germany; D006801:Humans; D007880:Legislation, Drug; D004366:Nonprescription Drugs; D055553:Prescription Drugs
chemical_list: D004366:Nonprescription Drugs; D055553:Prescription Drugs
keywords: Germany; Non-prescription drugs; Over-the-counter medicines; Rx-to-OTC switch