Dorothea von Bredow1, Massoud Toussi1, Abdus Samad2, Sigal Kaplan3, Mónika Domahidy4, Hanka de Voogd5, Stella Böhmert6, Rita Silveira Ramos7, Deepa Arora2. 1. Department of Pharmacoepidemiology and Drug Safety, IQVIA (formerly QuintilesIMS RWI), Courbevoie La Défense, France. 2. Department of Drug Safety and Risk Management, Lupin Limited, Kalpataru Inspire, Mumbai, India. 3. Department of Patient Safety & Pharmacovigilance, Teva Pharmaceutical Industries LTD, Petach Tikva, Israel. 4. Department of Clinical Research, Gedeon Richter Plc, Budapest, Hungary. 5. Department of Clinical Vaccines & Anti-Infectives, Mylan EPD, Amstelveen, Netherlands. 6. Department of Post-marketing Studies, Sandoz International GmbH, Holzkirchen, Germany. 7. Department of Scientific Affairs and Pharmacovigilance, Generis Farmacêutica, S.A., Amadora, Portugal.
Abstract
PURPOSE: In 2012, the Committee for Medicinal Products for Human Use (CHMP) restricted prescription of trimetazidine (TMZ) to "add-on therapy for patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line therapies." TMZ was no longer indicated for ophthalmology and otolaryngology. Risk minimization measure (RMM) was communicated to physicians. The survey presented here evaluated effectiveness of the RMM and assessed physicians knowledge and compliance with RMM. It also analyzed actual prescribing pattern of TMZ. METHODS: A cross sectional, web-based survey was developed and conducted among prescribing physicians of TMZ across 12 European countries. Physicians' samples were weighted to account for the actual proportion of specialties within and across countries. RESULTS: Using weighted samples, data from 1123 physicians and 8332 prescriptions were analyzed. Most (74.0%) of the physicians assumed stable angina pectoris to be an indication for TMZ. Three quarter of (75.7%) of these physicians were aware of the approved indication. Vertigo (62.1%), tinnitus (42.5%), declined visual acuity, and visual field disturbances (45.1%) were also presumed to be approved indications for TMZ, and physicians actually prescribed for these indications. Only 29.8% of the physicians remembered receiving RMM communications regarding TMZ. Most (90.5%) of the physicians expressed their interest to know and comply with the safety communications. Of all prescriptions, 33.9% were issued for add-on therapy for patients with stable angina pectoris. CONCLUSIONS: RMM for TMZ prescription have been moderately effective. Improvement in physician's compliance with safety information of TMZ is necessary for patient's safety.
PURPOSE: In 2012, the Committee for Medicinal Products for Human Use (CHMP) restricted prescription of trimetazidine (TMZ) to "add-on therapy for patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line therapies." TMZ was no longer indicated for ophthalmology and otolaryngology. Risk minimization measure (RMM) was communicated to physicians. The survey presented here evaluated effectiveness of the RMM and assessed physicians knowledge and compliance with RMM. It also analyzed actual prescribing pattern of TMZ. METHODS: A cross sectional, web-based survey was developed and conducted among prescribing physicians of TMZ across 12 European countries. Physicians' samples were weighted to account for the actual proportion of specialties within and across countries. RESULTS: Using weighted samples, data from 1123 physicians and 8332 prescriptions were analyzed. Most (74.0%) of the physicians assumed stable angina pectoris to be an indication for TMZ. Three quarter of (75.7%) of these physicians were aware of the approved indication. Vertigo (62.1%), tinnitus (42.5%), declined visual acuity, and visual field disturbances (45.1%) were also presumed to be approved indications for TMZ, and physicians actually prescribed for these indications. Only 29.8% of the physicians remembered receiving RMM communications regarding TMZ. Most (90.5%) of the physicians expressed their interest to know and comply with the safety communications. Of all prescriptions, 33.9% were issued for add-on therapy for patients with stable angina pectoris. CONCLUSIONS:RMM for TMZ prescription have been moderately effective. Improvement in physician's compliance with safety information of TMZ is necessary for patient's safety.
Authors: Seungyeon Kim; Yun Mi Yu; Jeongyoon Kwon; Kyeong Hye Jeong; Jeong Sang Lee; Euni Lee Journal: Int J Environ Res Public Health Date: 2020-10-04 Impact factor: 3.390