Evidence for benefits and risks of tadalafil as a non-prescription medicine: review and evaluation using the Group Delphi technique to achieve consensus amongst clinical experts

Frontiers in Pharmacology

Pharmacology

Uwe May¹  Michael Böhm²  Kurt Miller³  Wolf-Dietrich Beecken⁴  Georgios Hatzichristodoulou⁵  Stefan Fink⁶ 

[1] Department of Health Economics and Pharmacoeconomics, Fresenius University of Applied Sciences, Wiesbaden, Germany;Department of Internal Medicine, University of the Saarland, Homburg Saar, Germany;Department of Urology, Charité Campus Benjamin Franklin, Berlin, Germany;Department of Urology, Goethe University, Frankfurt, Germany;Martha-Maria Hospital Nuremberg, Nuremberg, Germany;State Pharmacists’ Association of Thuringia, Erfurt, Germany;

关键词: erectile dysfunction;    non-prescription;    phosphodiesterase type 5 inhibitor (PDE5 inhibitor);    reclassification;    tadalafil;   

DOI  :  10.3389/fphar.2023.1254706

 received in 2023-07-07, accepted in 2023-09-19,  发布年份 2023

来源: Frontiers

【 摘 要 】

An evidence-based consensus meeting was held with urologists, a pharmacist and a cardiologist to perform a structured benefit-risk analysis of reclassifying tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor for treatment of erectile dysfunction (ED), to be available without prescription in Germany. As per the Brass process endorsed by regulatory authorities, an evidence-based Brass value tree was developed, which identified the incremental benefits and risks that should be considered above the safety and efficacy evidence required for prescription medicines. During the Group Delphi consensus meeting, the expert panel rated the likelihood and clinical impact of each benefit and risk on a scale of 0 (none) to 3 (high). Overall attribute scores were calculated from the product of the mean likelihood and mean clinical impact scores giving a possible score of 0–9. The overall benefit attribute scores ranged from 2.8 to 5.4. The overall risk attribute scores ranged from 0.2 to 2.2 though most were 1.0 or less (3 or more is generally considered to be of concern). On balance, the independent meeting scored the benefits of reclassification of tadalafil higher than the risks and considered the risk mitigation strategies of the packaging label and patient information leaflet (PIL) sufficient.

【 授权许可】

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Copyright © 2023 Miller, May, Beecken, Hatzichristodoulou, Böhm and Fink.