gms | German Medical Science

21st Annual Meeting of the German Drug Utilisation Research Group (GAA), 9th German "Pharmakovigilanztag"

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

20.11.-21.11.2014, Bonn

Rebate contracts: reasons not to substitute

Meeting Abstract

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  • corresponding author presenting/speaker Eva-Maria Krieg - Deutsches Arzneiprüfungsinstitut e.V. (DAPI), Berlin, Germany
  • author Gabriele Gradl - Deutsches Arzneiprüfungsinstitut e.V. (DAPI), Berlin, Germany
  • author Martin Schulz - Deutsches Arzneiprüfungsinstitut e.V. (DAPI), Berlin, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 21. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie, 9. Deutscher Pharmakovigilanztag. Bonn, 20.-21.11.2014. Düsseldorf: German Medical Science GMS Publishing House; 2014. Doc14gaa28

doi: 10.3205/14gaa28, urn:nbn:de:0183-14gaa287

Published: November 18, 2014

© 2014 Krieg et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Background: Since 2007, German community pharmacies have been obliged to prioritize specific drug products in agreement with rebate contracts of statutory health insurance companies (GKV) when filling prescriptions (§ 130a (8) SGB V). However in individual circumstances, this generic substitution may compromise patient safety, drug effectiveness, and medication adherence. Therefore, pharmacies may express “pharmaceutical concerns“ on a prescription while dispensing another brand, usually the prescribed one. The aims of our investigation were to quantify pharmaceutical concerns as documented in claims data for GKV-prescriptions and to explore potential reasons by analyzing the specific drugs and dosage forms.

Materials and Methods: Data were extracted from the DAPI database which contains anonymized claims data of prescriptions filled at German community pharmacies at GKV expense. The database covers prescription data of more than 80 % of German community pharmacies. Since March 2011, reasons for not dispensing a rebate product have been documented (code 02567024 - deviating from rebate contract), including a specification of the pharmaceutical concern. We analyzed all prescriptions from July 2011 until June 2014 and investigated the top 20 active ingredients of concern including the dosage forms of the dispensed products. We were unable to analyze individual reasons as these are not coded.

Results: In the latest full-year available (2013), pharmaceutical concerns were expressed in 1.5% of all prescriptions in which a rebate drug should have been dispensed. All pharmaceutical concerns were considered plausible. The vast majority can be explained by a narrow therapeutic index and high risk of adverse effects (e.g., vitamin K antagonists, immunosuppressive drugs, opioids, thyroid hormones), by complex indications (e.g., neurological diseases and mental disorders) or by formulations which are difficult to use (e.g., extended-release tablets, patches/transdermal therapeutic systems e.g., for estradiol and fentanyl, as well as inhalers for asthma/COPD).

Conclusion: German community pharmacies expressed pharmaceutical concerns to a very limited extent. Non-observance of rebate contract-driven generic substitution is justified when patient safety or drug effectiveness is potentially compromised.