LAUSR

PURPOSE The Risk Minimization Measures (RMM) for systemic use of thiocolchicoside (TCC) were implemented across Europe during 2014-2016. RMM included restriction of use in age <16 years, maximum dose and duration, chronic conditions, contraindication in pregnancy, lactation or in women of child-bearing potential [WOCBP] without appropriate contraception. The current Drug Utilization Study was aimed to describe the prescribing practices of TCC in France and Italy. METHOD The study analyzed data (demographic, prescription, diagnosis, and concomitant treatment) from electronic medical record databases. It compares drug utilization during pre- (baseline: year 2013) and post- (years 1, 2, and 3) implementation of RMM. This study included panels of general practitioners (FGP) and rheumatologists (FRH) in France and Italy (IGP). RESULTS TCC was largely prescribed as adjuvant therapy in both pre- (FGP: 93.5%, FRH: 88.8%, IGP: 86.6%) and post-implementation (FGP: 92.3%, FRH: 89.5%, IGP: 89.0%) periods. Prescribing patterns were different in France and Italy, with FGP and FRH mainly prescribing oral formulation (>95% and >80%, respectively), while IGP prescribing intramuscular formulation (>70%). Prescriptions to patients aged ≥16 years were >99% in all panels during both periods. An improvement was observed in compliance to treatment duration for oral formulation in FGP panel post-implementation versus pre-implementation (66.2% vs. 46.7%; p<0.001). There was no change in prescription rate post RMM implementation in pregnant (FGP: 0.5%, IGP: 4.7%) and in WOCBP without appropriate contraception (FGP: 89.3%, IGP: 93.4%). CONCLUSION These results highlighted changes in prescribing practices of TCC after RMM implementation which varied across panels and measures. This article is protected by copyright. All rights reserved.