PhD Scientific Days 2022
Budapest, 6-7 July 2022
Pharmaceutical Sciences III. (Poster discussion will take place on the terrace of the room during the Coffee Break)
Tolperisone indication restriction: Effectiveness evaluation of related DHPCs
Előadó neve
Dr. Puhl, Eszter
Előadó munkahelye
Semmelweis University Department of Pharmacology and Pharmacotherapy
Előadó telefonszáma
706016549
Előadó e-mail címe
puhl.eszter@phd.semmelweis.hu
Az előadás címe
Tolperisone indication restriction: Effectiveness evaluation of related DHPCs
Szerző(k) neve és munkahelye
Eszter Puhl1, Szandra Márton1, Mátyás Pétervári1, Bence Ágg1,2, Péter Ferdinandy1,2
1 Cardiometabolic and MTA-SE System Pharmacology Research Group, Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary
2 Pharmahungary Group, Szeged, Hungary
Bemutatás módja
Poszter
Szekció
Pharmaceutical Sciences III. (Poster discussion will take place on the terrace of the room during the Coffee Break)
Language of the presentation
Hungarian
Preferred session
Health Sciences
Összefoglaló szövege
Introduction
Tolperisone is a centrally acting muscle relaxant that has been approved in many European countries for the treatment of muscle spasms and spasticities. Since 2003, several cases of life-threatening hypersensitivity reactions have been documented. Direct Healthcare Professional Communication letters (DHPCs) allow rapid communication of significant new drug safety information that affects the benefit-risk ratio of the products directly to the heathcare professionals (HCPs). In Hungary in 2013, a DHPC letter was sent on the indication restriction of tolperisone-containing medicines. Subsequently, another DHPC letter was sent in 2020, warning that tolperisone is still widely prescribed in deleted indications. The analysis of the effectiveness of DHPC letters is essential to ensure a favorable benefit-risk ratio. Currently, only the appropriate rate of receipt by HCPs is measured. It would be necessary to assess HCP’s knowledge on the topic using various methods.
Aims
We aimed to analyze the effect of indication restricting DHPC letters on tolperisone’s consumption in Hungary and to examine the prescribing habits of tolperisone-containing medicines.
Methods
Drug consumption data was accessed from National Health Insurance Fund of Hungary. From 2010 to 2021 yearly consumption was investigated in the light of DHPC distribution. Yearly frequency data of serious „Immune system disorders” ADR reports of tolperisone was retrieved from EudraVigilance (through www.adrreports.eu portal) and was compared with the yearly consumption.
Results
In the examined timeframe, the consumption of tolperisone showed a continuisly decreasing tendency which was not significantly changed in response to the two DHPC distribution. The yearly frequency of serious „Immune system disorders” ADR reports of tolperisone showed no clear tendencies.
Conclusion
The example of tolperisone shows that the desired behavioral changes of HCPs do not develop even after years, which may negatively affect the safety of the therapy and puts the patients at risk. New tools for DHPC effectiveness evaluation are needed.
Funding
PE was supported by EFOP-3.6.3-VEKOP-16-2017-00009 grant.
University and Doctoral School
Semmelweis University, Doctoral School of Pharmaceutical Sciences
Supervisor
Péter Ferdinandy, MD, PhD, DSc, MBA
Publication of my abstract
I do not give consent to the publication of my abstract on the website of the congress.
Kind
Szabad
Status
elfogadva
Accepted presentation method
poszter
Előadás fájl jóváhagyás
nem rendelkezett róla
Előadó
6032
Start
13:25
End
13:30
Authors (legacy)
Eszter Puhl1, Szandra Márton1, Mátyás Pétervári1, Bence Ágg1,2, Péter Ferdinandy1,2
1 Cardiometabolic and MTA-SE System Pharmacology Research Group, Department of Pharmacology and Pharmacotherapy, Semmelweis University, Budapest, Hungary
2 Pharmahungary Group, Szeged, Hungary