Poster Session B - Pharmaceutical Sciences and Health Technologies 1.
Dr. Marton, Szandra
F7X1C9
Department of Pharmacology and Pharmacotherapy
+36205622962
marton.szandra@semmelweis.hu
Prescribing Habits of Tolperisone in Hungary: the Effect of Indication Restriction and Direct Healthcare Professional Communication Letters
Szandra Marton1, Eszter Puhl1, Mátyás Pétervári1,2, Zsolt Varga3, Péter Ferdinandy1,4, Bence Ágg1,4
1: HUN-REN–SU System Pharmacology Research Group, Department of Pharmacology and Pharmacotherapy, Semmelweis University
2: Sanovigado Ltd.
3: Centre of Science & Innovations Vice-Rector and Business Development, Semmelweis University
4: Pharmahungary Group
Poszter
Poster Session B - Pharmaceutical Sciences and Health Technologies 1.
English
Pharmaceutical Sciences and Health Technologies
Introduction
Tolperisone is a centrally acting muscle relaxant used to treat spasms and spasticity. Due to life-threatening hypersensitivity reactions reported since 2003, the European Medicines Agency (EMA) decided to restrict its use to post-stroke spasticity in adults. The Hungarian National Institute of Pharmacy and Nutrition issued direct healthcare professional communication (DHPC) letters in 2013 and 2020. These DHPC letters warned healthcare professionals about the associated risks and indication restriction.
Aims
We aimed to evaluate the effect of DHPC letters for tolperisone on the indication of prescription trends in Hungary.
Method
We examined indication data categorized by ICD-10 codes to track the prescribed use of tolperisone-containing medications. We analyzed the prescription trends before the first DHPC letter, between the two letters, and after the second letter. Indication data were sourced from the National Health Insurance Fund of Hungary.
Results
Our analysis of Hungarian prescriptions revealed that the 10 most prescribed indications were musculoskeletal disorders after the first DHPC letter. The on-label indication still ranked low (9th place) after the second letter, pointing to concerning off-label use.
Conclusion
The Hungarian DHPC letters had a minimal impact on the prescribing habits for tolperisone. Although there was a slight shift towards appropriate use, a substantial portion of prescriptions continued to fall outside the recommended indications. Regularly evaluating the effectiveness of DHPC letters and monitoring off-label use would contribute to the safe use of medications.
Funding
This study has been supported by a Semmelweis 250+ Excellence Fellowship to Szandra Marton, MD.
This project has received funding from the HUN-REN Hungarian Research Network.
Project no. RRF-2.3.1-21-2022-00003 has been implemented with the support provided by the European Union.
Semmelweis University
Péter Ferdinandy, MD, PhD, DSc, MBA and Bence Ágg, MD, PhD
I do not give consent to the publication of my abstract on the website of the congress.
Szabad
elfogadva
poszter
nem rendelkezett róla
8088
14:55
14:58