Epidemiology and Benefit-Risk, Research and Development, Sanofi, Chilly-Mazarin, France.
Real-world Solutions, IQVIA, Courbevoie, France.
Pharmacoepidemiol Drug Saf. 2023 Oct;32(10):1093-1102. doi: 10.1002/pds.5611. Epub 2023 May 30.
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.
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).
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%).
These results highlighted changes in prescribing practices of TCC after RMM implementation, which varied across panels and measures.
2014 年至 2016 年期间，在欧洲范围内实施了硫代秋水仙碱（TCC）全身用药的风险最小化措施（RMM）。RMM 包括限制 16 岁以下儿童使用、最大剂量和使用期限、慢性疾病、妊娠、哺乳期或有生育能力的女性（WOCBP）无适当避孕措施时禁用。本项药物利用研究旨在描述法国和意大利 TCC 的处方实践。
该研究分析了电子病历数据库中的人口统计学、处方、诊断和伴随治疗数据。比较了 RMM 实施前（基线：2013 年）和实施后（第 1、2 和 3 年）的药物利用情况。本研究包括法国和意大利的全科医生（FGP）和风湿病医生（FRH）小组（IGP）。
TCC 在实施前（FGP：93.5%，FRH：88.8%，IGP：86.6%）和实施后（FGP：92.3%，FRH：89.5%，IGP：89.0%）期间主要作为辅助治疗处方。法国和意大利的处方模式不同，FGP 和 FRH 主要开口服制剂（分别>95%和>80%），而 IGP 则开肌内制剂（>70%）。所有小组在两个时期内，≥16 岁患者的处方率均>99%。FGP 小组口服制剂的治疗持续时间符合率在实施后与实施前相比有所提高（66.2%比 46.7%；p<0.001）。RMM 实施后，孕妇（FGP：0.5%，IGP：4.7%）和无适当避孕措施的 WOCBP（FGP：89.3%，IGP：93.4%）的处方率没有变化。
这些结果突出了 RMM 实施后 TCC 处方实践的变化，这些变化因小组和措施而异。
