Shortage of antiseizure medication in Germany: How big is the problem?

Autor: Steidl J; Department of Neurology, Epilepsy Center Erlangen, Full Member of ERN EpiCARE, University Hospital Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany. Electronic address: josephine.steidl@uk-erlangen.de., Krebs S; Pharmacy Department, Erlangen University Hospital, Erlangen, Palmsanlage 3, 91054 Erlangen, Germany., Kostev K; IQVIA, Epidemiology, Frankfurt Am Main, Main Airport Center, Unterschweinstiege 2-14, 60549 Frankfurt Am Main, Germany., Schwab S; Department of Neurology, Epilepsy Center Erlangen, Full Member of ERN EpiCARE, University Hospital Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany., Hamer HM; Department of Neurology, Epilepsy Center Erlangen, Full Member of ERN EpiCARE, University Hospital Erlangen, Schwabachanlage 6, 91054 Erlangen, Germany.
Jazyk: angličtina
Zdroj: Epilepsy & behavior : E&B [Epilepsy Behav] 2025 Jan; Vol. 162, pp. 110162. Date of Electronic Publication: 2024 Nov 29.
DOI: 10.1016/j.yebeh.2024.110162
Abstrakt: Objectives: We determined the frequency of drug shortages of antiseizure medication (ASM) availability in Germany.
Methods: Retrospective and descriptive analysis of databases of 2 pharmaceutical wholesalers in Germany with a market share of about 45% of the German market in July 2023 (chosen arbitrarily) focusing on antiseizure drug shortages (i.e. demand could not be met entirely) and disruptions (i.e. demand could not be met at all) on the level of formulations, ASM and of manufacturers.
Results: 98/909 (10.8%) of formulations of ASM with Wholesaler A were listed with drug shortages and 131/872 (15%) of formulations were reported with drug shortages at Wholesaler B. 19 of 222 (8.6%) entire ASM at Wholesaler A and 12/213 (5.6%) of ASM with Wholesaler B were reported with drug shortages. 41/62 (66.1%) manufacturers at wholesaler A and 36/57 (63.2%) manufacturers at wholesaler B reported shortages. The three compounds affected most frequently by drug shortages were pregabalin, levetiracetam and carbamazepine. 1.7% (Wholesaler A) and 12.9% (Wholesaler B) of formulations were listed with disruptions. 16.7% (40/239) of ASM with drug shortages/disruptions were brand-name ASM and 83.3% (199/239) were generic ASM.
Conclusions: 11% to 15% of ASM formulations had drug shortages in Germany in July 2023. Generic ASM were more frequently affected than brand-name ASM. About 2/3 of manufacturers were reported to have drug shortages.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [HM Hamer has served on the scientific advisory board of Angelini, UniQure, Eisai, GW/Jazz, UCB Pharma. He served on the speakers’ bureau of or received unrestricted grants from Angelini, Ad-Tech, Alnylam, Bracco, Desitin, Eisai, Jazz, LivaNova, Nihon Kohden, Pfizer and UCB Pharma. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper].
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: