Abstract
Allergologie select, Vol. 8/2024 (251-264)
Possible manufacture of test allergens in public pharmacies for the diagnosis of type I allergies: Legal aspects
Robin Jost1,2, Sabine Kespohl3, Kathrin E. Paulus-Tremel1, Julia Zimmer1, Andreas Bonertz1, Ingrid Sander3, Thomas Klose4, Lena-Maria Altin4, Simone Heller4, Ralph Heimke-Brinck5, Frank Dörje5, Susanne Philippus6, Matthias Meyer7, Sabrina Segebrecht8, Torsten Wessel9, Dieter Starke10, Stefan Schülke1, Monika Raulf3, and Vera Mahler1,2
1Allergology Division, Paul-Ehrlich-Institut (PEI), Langen (Hesse), 2Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, 3Institute for Prevention and Occupational Medicine of the German Social Accident Insurance (DGUV), Institute of the Ruhr-Universität Bochum (IPA), Bochum, 4Sonnenschein Apotheke, Koblenz, 5Pharmacy Department, Erlangen University Hospital, Erlangen, 6Thuringian State Authority for Consumer Protection, Department Pharmacy, Bad Langensalza, 7Bundeswehr Commissioner for the Surveillance of Medicinal Products, Supervisory Agency for Public Law Tasks of the Bundeswehr Medical Service South, Munich, 8Drug Supervision, State Social Services Agency of Land Schleswig-Holstein, Neumünster, 9Pharmacy Inspector, Local inspectorate for pharmacies, District of Wesel, Moers, and 10 State Agency for Social Affairs, Youth and Care, Rhineland-Palatinate, Koblenz, Germany
The availability of high-quality skin test allergens is a prerequisite for the reliable diagnosis of occupational type I allergies. Due to the withdrawal of existing marketing authorizations (MAs) by pharmaceutical companies and the lack of new MAs for commercial test allergens, there is an increasing diagnostic gap in Germany and other EU member states, which makes it necessary to investigate alternative ways of providing in vivo diagnostics. The German Medicinal Products Act (Arzneimittelgesetz = AMG) allows for the possibility of preparing medicinal products in pharmacies without the need for an MA or a manufacturing authorization pursuant to Section 13 (2) No. 1 in conjunction with Section 13 (2a) Sentence 2 No. 3 AMG. This also includes test allergens. In addition to the AMG, the requirements of the German Ordinance on the Operation of Pharmacies (Apothekenbetriebsordnung – ApBetrO) and the European Pharmacopoeia apply in particular. Medicolegal and practical challenges, as well as potentials of manufacturing skin prick test solutions in public pharmacies are presented based on examples of different allergen source materials.Correspondence to:
Prof. Dr. Vera Mahler, Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, 63225 Langen, Germany
Email: [email protected]
