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Original

Procedure for a standardized preparation of skin prick test solutions for the diagnosis of occupational type I allergies in the absence of commercial extracts

Sabine Kespohl, Robin Jost, Silke Maryska, Lena-Maria Altin, Ingrid Sander, Stefan Schülke, Kathrin E. Paulus-Tremel, Andreas Bonertz, Thomas Klose, Vera Mahler, and Monika Raulf

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Volume 8 (2024) p. 238 - 250

Abstract

Allergologie select, Vol. 8/2024 (238-250)

Procedure for a standardized preparation of skin prick test solutions for the diagnosis of occupational type I allergies in the absence of commercial extracts

Sabine Kespohl¹, Robin Jost², Silke Maryska¹, Lena-Maria Altin³, Ingrid Sander¹, Stefan Schülke², Kathrin E. Paulus-Tremel², Andreas Bonertz², Thomas Klose³, Vera Mahler², and Monika Raulf¹

¹Institute for Prevention and Occupational Medicine of the DGUV, Ruhr-University Bochum (IPA), Bochum, ²Division Allergology, Paul-Ehrlich-Institut, Langen, and ³Sonnenschein Apotheke, Koblenz, Germany
In order to ensure valid diagnostics for occupational test allergen solutions despite the ongoing reduction in the availability of commercial test extracts, a plan B was initiated for the possible production of skin prick test (SPT) solutions in public pharmacies. For important occupational allergen sources (wheat and rye, storage mites, animal epithelia, mold material) laboratory extraction methods were analyzed in comparison to pharmacy compatible extraction methods regarding protein quantity and quality in SDS-PAGE combined with silver staining. Subsequently, using the example of bovine epithelia, adapted extraction procedures as well as in-process and final product controls were transferred to a public pharmacy. Allergen sources with a high protein content, such as wheat and rye grains as well as storage mites, showed good comparability of the extractable protein quantity and protein pattern, regardless of the applied extraction method. In contrast, allergen source materials with a low total protein content, such as animal epithelia and molds, can benefit from laboratory extraction conditions such as mechanical disruption and specific buffer additives. In the qualitative protein silver staining, characteristic protein patterns were identified for each allergen source. Depending on the extraction method, only minor differences in total protein patterns were observed in animal epithelia and molds. Using source materials from two suppliers, the resulting allergen extracts displayed clear differences in protein content in storage mites and quantitative and qualitative differences in molds. A practical preparation attempt of SPT solutions in a public pharmacy was successful. SPT solutions prepared with adapted pharmacy extraction methods showed a comparable protein and Bos d 2 allergen content and equivalent qualities in the protein pattern compared to a previously available commercial SPT solution. Accordingly, it can be assumed that standardized SPT solutions with sufficient allergen quality for occupational allergen sources can be prepared in public pharmacies if certified allergen sources with appropriate protein content are available.Correspondence to:
Dr. Sabine Kespohl, Institute for Prevention and Occupational Medicine of the German Social Accident Insurance, Institute of the Ruhr-Universität Bochum (IPA), Department Competence Center Allergology/Immunology, Bürkle-de-la-Camp-Platz 1, 44789 Bochum, Germany
Email: [email protected]

Review

Possible manufacture of test allergens in public pharmacies for the diagnosis of type I allergies: Legal aspects

Robin Jost, Sabine Kespohl, Kathrin E. Paulus-Tremel, Julia Zimmer, Andreas Bonertz, Ingrid Sander, Thomas Klose, Lena-Maria Altin, Simone Heller, Ralph Heimke-Brinck, Frank Dörje, Susanne Philippus, Matthias Meyer, Sabrina Segebrecht, Torsten Wessel, Dieter Starke, Stefan Schülke, Monika Raulf, and Vera Mahler

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Volume 8 (2024) p. 251 - 264

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]

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