A drug utilization study of thiocolchicoside-containing medicinal products for systemic use in France and Italy: A cross-sectional electronic medical records database study.

Publisher: Wiley Country of Publication: England NLM ID: 9208369 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1099-1557 (Electronic) Linking ISSN: 10538569 NLM ISO Abbreviation: Pharmacoepidemiol Drug Saf Subsets: MEDLINE

Original Publication: Chichester, West Sussex : Wiley, 1992-

Electronic Health Records* ; Drug Utilization*; Pregnancy ; Humans ; Female ; Cross-Sectional Studies ; France/epidemiology ; Italy ; Practice Patterns, Physicians'

Purpose: The risk minimization measures (RMM) for systemic use of thiocolchicoside (TCC) was 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 childbearing 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-implementation (baseline: year 2013) and post-implementation (years 1, 2, and 3) 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-implementation (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 with treatment duration for oral formulation in the 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.
(© 2023 Sanofi Winthrop Industrie. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.)

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Keywords: contraception; drug utilization study; prescription; risk minimization measures; safety; thiocolchicoside

T1X8S697GT (thiocolchicoside)

Date Created: 20230315 Date Completed: 20230906 Latest Revision: 20231010

20231010

10.1002/pds.5611

36919414