Status of Emergency Contraceptives in Europe One Year after the European Medicines Agency's Recommendation to Switch Ulipristal Acetate to Non-Prescription Status

摘要

Background: In November 2014, the European Medicines Agency (EMA) recommended switching the emergency contraceptive (EMC) ulipristal acetate to non-prescription status. This study's objective is to assess the current legal status of the two EMCs ulipristal acetate and levonorgestrel in Europe and to report on the development of sales figures for EMCs since they were made freely available. Methods: Health authorities were contacted in autumn 2015 and asked about the current status of EMCs and whether the sales figures had changed after a switch to non-prescription status. Additionally, data on consumption were collected in 18 German community pharmacies. Results: As of November 2015, most countries in the European Union (EU) have followed the EMA recommendation. Hungary kept the prescription-only status. In Malta, EMC drugs are not authorized. Germany and Croatia switched levonorgestrel to non-prescription status as well. Of the EU candidate and European Free Trade Association countries, ulipristal acetate is available without prescription in Norway and Bosnia and Herzegovina only. Several countries reported an increase in EMC sales since the switch. Conclusions: An EMA recommendation can strongly contribute to the harmonization of a drug's legal status in the EU. In most European countries, ulipristal acetate and/or levonorgestrel are now freely available. (C) 2016 The Author(s) Published by S. Karger AG, Basel