CHU Nantes, Service de Pharmacologie Clinique-Centre d'Evaluation et d'Information sur la Pharmacovigilance-Addictovigilance, Nantes Université, F-44000 Nantes, France.
Univ Tours, CHU Nantes, INSERM, MethodS in Patient-Centered Outcomes & HEalth ResEarch, Nantes Université, SPHERE, F-44000 Nantes, France.
Int J Environ Res Public Health. 2022 Jul 22;19(15):8920. doi: 10.3390/ijerph19158920.
Background: The French national drug regulatory authority stated, in 2017, that a secured prescription pad must be used for zolpidem prescriptions. This study aimed to evaluate the evolution of the problematic consumption of zolpidem at the individual level since the new regulation. Methods: Two nationwide populations of at-risk users of zolpidem were recruited: one in general practitioner (GP) offices and one in specialized care centers dedicated to drug dependence (SCDDs). Participants were asked about their zolpidem consumption before and after the regulation change. The primary outcome was the evolution of problematic zolpidem consumption, as defined by at least one of the following criteria: overconsumption, fraudulent ways of obtaining, effects sought other than hypnotic, and modes of administration other than oral. Results: A total of 243 participants were included: 125 from GP offices and 118 from SCDDs. In the GP population, the prevalence of patients who were identified as problematic consumers decreased from 24.8% to 20.8% (p = 0.593), whereas the prevalence decreased from 73.7% to 51.7% in the SCDD population (p < 0.001). The most prevalent criteria for problematic status were overconsumption and fraudulent ways. Conclusions: The new French regulation of zolpidem had different impacts among two different populations of at-risk zolpidem consumers.
法国国家药品监管局于 2017 年规定,开具唑吡坦处方必须使用安全处方笺。本研究旨在评估自新规定实施以来,个体层面唑吡坦问题性使用的演变情况。
在全科医生(GP)诊所和专门的药物依赖治疗中心(SCDD)中招募了两个有风险使用唑吡坦的全国性人群。参与者被问及他们在规定改变前后的唑吡坦使用情况。主要结局是定义为以下至少一个标准的问题性唑吡坦使用的演变:过度使用、欺诈性获取、寻求催眠以外的效果和非口服给药方式。
共纳入 243 名参与者:125 名来自 GP 诊所,118 名来自 SCDD。在 GP 人群中,被确定为问题性消费者的患者比例从 24.8%降至 20.8%(p = 0.593),而 SCDD 人群中这一比例从 73.7%降至 51.7%(p < 0.001)。问题性状态最常见的标准是过度使用和欺诈性获取。
法国对唑吡坦的新监管规定对两种不同的唑吡坦风险消费者群体产生了不同的影响。