Evidence map›Paper›PMID 39055748›Full record

ReviewAllergologie select2024

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 and 9 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Allergologie select, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Robin JostAllergology Division, Paul-Ehrlich-Institut (PEI), Langen (Hesse).
Sabine KespohlInstitute for Prevention and Occupational Medicine of the German Social Accident Insurance (DGUV), Institute of the Ruhr-Universität Bochum (IPA), Bochum.
Kathrin E Paulus-TremelAllergology Division, Paul-Ehrlich-Institut (PEI), Langen (Hesse).
Julia ZimmerAllergology Division, Paul-Ehrlich-Institut (PEI), Langen (Hesse).
Andreas BonertzAllergology Division, Paul-Ehrlich-Institut (PEI), Langen (Hesse).
Ingrid SanderInstitute for Prevention and Occupational Medicine of the German Social Accident Insurance (DGUV), Institute of the Ruhr-Universität Bochum (IPA), Bochum.
Thomas KloseSonnenschein Apotheke, Koblenz.
Lena-Maria AltinSonnenschein Apotheke, Koblenz.
Simone HellerSonnenschein Apotheke, Koblenz.
Ralph Heimke-BrinckPharmacy Department, Erlangen University Hospital, Erlangen.
Frank DörjePharmacy Department, Erlangen University Hospital, Erlangen.
Susanne PhilippusThuringian State Authority for Consumer Protection, Department Pharmacy, Bad Langensalza.
Matthias MeyerBundeswehr Commissioner for the Surveillance of Medicinal Products, Supervisory Agency for Public Law Tasks of the Bundeswehr Medical Service South, Munich.
Sabrina SegebrechtDrug Supervision, State Social Services Agency of Land Schleswig-Holstein, Neumünster.
Torsten WesselPharmacy Inspector, Local inspectorate for pharmacies, District of Wesel, Moers, and.
Dieter StarkeState Agency for Social Affairs, Youth and Care, Rhineland-Palatinate, Koblenz, Germany.
Stefan SchülkeAllergology Division, Paul-Ehrlich-Institut (PEI), Langen (Hesse).
Monika RaulfInstitute for Prevention and Occupational Medicine of the German Social Accident Insurance (DGUV), Institute of the Ruhr-Universität Bochum (IPA), Bochum.
Vera MahlerAllergology Division, Paul-Ehrlich-Institut (PEI), Langen (Hesse).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

diagnostic gapEuropean Pharmacopoeia (Ph. Eur.)finished medicinal productGerman Medicinal Products Act (AMG)marketing authorizationoccupational allergyOrdinance on the Operation of Pharmacies (ApBetrO)pharmacy manufacturingquality assuranceskin prick testing

Identifiers

PMID39055748
PMCPMC11270336

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.