Trimm Kevin, Moraga Maria-Teresa, Knäuper Bärbel, Rahme Elham, Gibson McDonald Emily, Tamblyn Robyn
Department of Experimental Medicine, McGill University, 845 Sherbrooke Street West, Montreal, QC, H3A 2T5, Canada.
Department of Epidemiology, Biostatistics, Occupational Health, McGill University, Montreal, QC, Canada.
Clin Drug Investig. 2025 Sep 5. doi: 10.1007/s40261-025-01476-1.
Benzodiazepines are commonly prescribed medications approved for and used in the treatment of anxiolytic and sleep disorders, as well as for seizures, and alcohol withdrawal. However, benzodiazepines are also controlled substances because of their potential for abuse and personal harm, which are especially prevalent among older people. It is therefore important to understand how benzodiazepines are being prescribed, and the prevalence of off-label benzodiazepine prescribing, of which very little is known because of challenges in documenting treatment indication. The aim of this study was to detail the prevalence of benzodiazepine off-label prescribing.
Data from the MOXXI (Medical Office of the XXIst century) electronic health record system in Quebec Canada were used, where specifying the treatment indication for each prescription is required, to estimate the prevalence of off-label prescribing and indications for off-label use of benzodiazepines. Each drug indication was retrospectively classified as either on-label or off-label according to the Health Canada drug database. Off-label prescriptions were further classified as having class congruence supporting their prescription if another benzodiazepine had been approved for the indication by Health Canada.
There were 20,125 (17.0%) adult patients prescribed benzodiazepines out of the 118,223 patients enrolled in the MOXXI system. The patients were predominantly female (65.6%) and tended to be older with an average age of 60.14 years at the time of the first benzodiazepine prescription. A total of 101,583 unique prescriptions were written for 14 different benzodiazepines. An approximately equal number of benzodiazepines were prescribed on- and off-label (49.3% on-label, 49.2% off-label). Most off-label prescription indications were classified as having class congruence (95.2%).
Benzodiazepines were frequently prescribed in the province of Quebec and were prescribed off-label approximately half of the time. When prescribed off-label, we found that most of these prescriptions were for indications that were approved for other benzodiazepines. The most common indication for off-label benzodiazepine prescriptions with class congruence was insomnia.
苯二氮䓬类药物是常用处方药，被批准用于治疗焦虑症和睡眠障碍、癫痫以及酒精戒断。然而，由于其存在滥用和对个人造成伤害的可能性，苯二氮䓬类药物也受到管控，这种情况在老年人中尤为普遍。因此，了解苯二氮䓬类药物的处方开具方式以及超说明书用药的发生率非常重要，由于记录治疗指征存在挑战，目前对此了解甚少。本研究的目的是详细阐述苯二氮䓬类药物超说明书用药的发生率。
使用加拿大魁北克省MOXXI（21世纪医疗办公室）电子健康记录系统的数据，该系统要求明确每张处方的治疗指征，以估计苯二氮䓬类药物超说明书用药的发生率及其超说明书使用的指征。根据加拿大卫生部药品数据库，将每种药物指征回顾性分类为说明书用药或超说明书用药。如果加拿大卫生部已批准另一种苯二氮䓬类药物用于该指征，则超说明书处方进一步分类为具有支持其处方的类别一致性。
在MOXXI系统登记的118,223名患者中，有20,125名（17.0%）成年患者开具了苯二氮䓬类药物处方。患者以女性为主（65.6%），年龄偏大，首次开具苯二氮䓬类药物处方时的平均年龄为60.14岁。共为14种不同的苯二氮䓬类药物开具了101,583张独特的处方。说明书用药和超说明书用药的苯二氮䓬类药物数量大致相等（说明书用药占49.3%，超说明书用药占49.2%）。大多数超说明书处方指征被分类为具有类别一致性（95.2%）。
魁北克省经常开具苯二氮䓬类药物处方，约一半时间为超说明书用药。当超说明书用药时，我们发现这些处方大多用于已被批准用于其他苯二氮䓬类药物的指征。具有类别一致性的超说明书苯二氮䓬类药物处方最常见的指征是失眠。
