Non-prescription dispensing of emergency oral contraceptives: Recommendations from the German Federal Chamber of Pharmacists [Bundesapothekerkammer].

Main Article Content

Martin Schulz
Ralf Goebel
Claudia Schumann
Petra Zagermann-Muncke


Contraception, Postcoital, Community Pharmacy Services, Pharmacies, Practice Guidelines as Topic, Germany


Background: Emergency hormonal contraceptives (EHC) are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse (USI) or contraceptive failure. The EHCs available without a prescription include medicines containing levonorgestrel (LNG) in more than 80 countries and, recently, based on an EU-switch ellaOne®, which contains ulipristal acetate (UPA). EHCs work by stopping or delaying ovulation. Those containing LNG can be used up to 72 hours after USI or contraceptive failure, while UPA can be used up to 120 hours. In the context of the UPA implementation process, Germany switched LNG to non-prescription status as well. 

Objectives: To develop recommendations, a protocol, and a continuing education program for pharmacists to assure quality when giving advice and dispensing EHCs in community pharmacies without a medical prescription.

Methods: The recommendations were developed by an iterative process of drafting, recognizing, and discussing comments and proposals for amendments as well a seeking agreement with a number of stakeholders such as the Federal Ministry of Health (BMG), Federal Institute for Drugs and Medical Devices (BfArM), Federal Chamber of Physicians (BÄK), Drug Commission of German Physicians (AkdÄ), professional organizations/associations of gynaecologists, pharmaceutical OTC-industry as well as government-controlled, private, and church-based organizations and centres providing advice on sex education and family planning.

Results: The recommendations were eventually endorsed by the BMG in consultation with the BfArM.

Conclusions: The recommendations were made public, published in the professional journal and used in an uncounted number of continuing education programs based on the curriculum and provided by the State Chambers of Pharmacists.

Abstract 1896 | PDF Downloads 1054 online appendix Downloads 1851 Appendix 1 Downloads 355 Appendix 2 Downloads 343 Curriculum Downloads 263


1. Italia S, Brand H. Status of emergency contraceptives in Europe one year after the European Medicines Agency's recommendation to switch ulipristal acetate to non-prescription status. Public Health Genomics. 2016;19(4):203-10. doi: 10.1159/000444686

2. Schneider CR, Gudka S, Fleischer L, Clifford RM. The use of a written assessment checklist for the provision of emergency contraception via community pharmacies: a simulated patient study. Pharm Pract (Granada). 2013;11(3):127-131.

3. European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP). ellaOne assessment report. EMA/73099/2015, 4 December 2014, rev 1. Procedure No. EMEA/H/C/001027/II/0021. (accessed 19 June 2016).

4. HRA-Pharma. Norlevo – Summary of Product Characteristics.

5. EMA. EPAR ellaOne including Summary of Products Characteristics (SPC) and package leaflet. (accessed 19 June 2016).

6. German Federal Chamber of Pharmacists [Bundesapothekerkammer, BAK]. Information sheet for the dispensing of medicinal products to children. Quality assurance guideline – version as of 13 November 2013. (accessed 19 June 2016).

7. European Medicines Agency (EMA). Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight. (accessed 19 June 2016).

8. Federal Ministry of Health. Ordinance of the Operation of Pharmacies (Apothekenbetriebsordnung, ApBetrO). Version as published on 26 September 1995 (Federal Law Gazette I p. 1195), last amended pursuant to Article 2a of the Ordinance amending the Drug Prescription Ordinance and the Ordinance on the Operation of Pharmacies on 6 March 2015 (Federal Law Gazette I p. 278). (accessed 19 June 2016).

9. Pfeil D, Pieck J, Blume H (eds.) Apothekenbetriebsordnung (ApBetrO). Kommentar mit Textsammlung [Commentary on the Ordinance of the Operation of Pharmacies]. Govi Publ. Co., Eschborn. 11th Supplement 2014, pp. 66–69.

10. Cheng L, Che Y, Gülmezoglu AM. Interventions for emergency contraception. Cochrane Database Syst Rev. 2012;(8):CD001324. doi: 10.1002/14651858.CD001324.pub4

11. European Medicines Agency (EMA). Assessment report on emergency contraceptives. (accessed 3 June 2016).

12. Federal Institute for Drugs and Medical Devices (BfArM). Levonorgestrel and higher body weight or body mass index (BMI) – decision. 75.03-3822-V-16018/601411/14, 5 November 2014. (accessed 19 June 2016).