Insufficient correctness of package inserts for psychotropic drugs in Germany.
Comprehensibility
MGPCR antagonists
NE/5-HT enhancers
Package insert
Potential for improvement
Journal
Naunyn-Schmiedeberg's archives of pharmacology
ISSN: 1432-1912
Titre abrégé: Naunyn Schmiedebergs Arch Pharmacol
Pays: Germany
ID NLM: 0326264
Informations de publication
Date de publication:
20 Sep 2024
20 Sep 2024
Historique:
received:
16
05
2024
accepted:
31
08
2024
medline:
20
9
2024
pubmed:
20
9
2024
entrez:
20
9
2024
Statut:
aheadofprint
Résumé
Package inserts often cause displeasure among patients as they are perceived as misleading and confusing. The aim of this study was to find out how comprehensible, complete, and truthful package inserts are formulated in Germany. 311 package inserts for antipsychotics (mGPCR antagonists) and antidepressants (NE/5-HT enhancers) from different manufacturers and dosages were analysed. The analysis criteria included the description of the effect, the warning of increased suicide risk, the explanation of interactions with co-medication, food and stimulants, as well as alcohol and the warning of impaired roadworthiness. In addition, the timeliness of the information regarding pregnancy and breastfeeding was checked and the symptoms mentioned under the topic of discontinuation symptoms and adverse drug reactions were compared. For most parameters, inconsistencies among various products, deficiencies and incorrect information were noted. This was particularly true for the items pregnancy and breastfeeding. Thus, package inserts for mGPCR antagonists and NE/5-HT enhancers need to be updated and standardised urgently. Such measures will reduce confusion among patients and increase drug adherence.
Identifiants
pubmed: 39302419
doi: 10.1007/s00210-024-03430-y
pii: 10.1007/s00210-024-03430-y
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s).
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