García-Sempere Aníbal, Hurtado Isabel, Peiró Salvador, Sánchez-Sáez Francisco, Rodríguez-Bernal Clara Liliana, Puig-Ferrer Magda, Escolano Manuel, Sanfélix-Gimeno Gabriel
Foundation for the Promotion of Health and Biomedical Research of Valencia Region, FISABIO, Valencia, Spain.
Spanish Network for Chronic Health Services Research, REDISSEC, Valencia, Spain.
Front Pharmacol. 2022 Apr 5;13:815719. doi: 10.3389/fphar.2022.815719. eCollection 2022.
The Spanish health authorities are concerned by the off-label use of immediate-release formulations of fentanyl (IRF) in noncancer pain and cancer pain in patients with no chronic pain therapy. To evaluate the impact of different interventions to improve appropriateness of IRF prescription on off-label prescription. We used interrupted time series (ITS) to estimate immediate and trend changes of IRF prescription for noncancer pain (NCP) and breakthrough cancer pain (BCP) in patients with and without chronic cancer pain therapy associated with two medication reviews (I1 and I2) and the issue of a safety warning letter (I3) with data from a Spanish region with 5 million inhabitants, from 2015 to 2018. The use of IRF for NCP in the region Valencia was reduced from about 1,800 prescriptions per week to around 1,400. The first medication review was followed by an immediate level change of -192.66 prescriptions per week ( < 0.001) and a downward trend change of -6.75 prescriptions/week ( < 0.001), resulting in a post-intervention trend of -1.99 ( < 0.001). I2 was associated with a trend change of -23.07 ( < 0.001) prescriptions/week. After I3, the trend changed markedly to 27.23 additional prescriptions/week, for a final post-intervention trend of 2.17 ( < 0.001). Controlled-ITS provided comparable results. For potentially inappropriate BCP use, the second medication review was followed by a downward, immediate level change of -10.10 prescriptions/week ( = 0.011) and a trend change of 2.31 additional prescriptions/week ( < 0.001) and the issue of the safety warning (I3) was followed by a downward trend change of -2.09 prescriptions/week ( = 0.007). Despite IRF prescription for NCP decreased, the interventions showed modest and temporary effect on off-label prescription. Our results call for a review of the design and implementation of safety interventions addressing inappropriate opioid use.
西班牙卫生当局对芬太尼速释制剂（IRF）在无慢性疼痛治疗的患者的非癌性疼痛和癌性疼痛中的标签外使用表示关注。为评估不同干预措施对改善IRF处方适宜性以减少标签外处方的影响。我们采用中断时间序列（ITS）来估计2015年至2018年期间，在一个拥有500万居民的西班牙地区，与两次用药评估（I1和I2）以及发出安全警告信（I3）相关的、有无慢性癌痛治疗的患者中，非癌性疼痛（NCP）和突破性癌痛（BCP）的IRF处方的即时变化和趋势变化。该地区瓦伦西亚NCP的IRF使用量从每周约1800张处方减少到约1400张。第一次用药评估后，每周即时水平变化为-192.66张处方（<0.001），每周下降趋势变化为-6.75张处方/周（<0.001），干预后趋势为-1.99（<0.001）。I2与每周-23.07张处方（<0.001）的趋势变化相关。I3之后，趋势显著变为每周增加27.23张处方，干预后最终趋势为2.17（<0.001）。对照ITS提供了可比结果。对于潜在不适当的BCP使用，第二次用药评估后，每周即时水平下降变化为-10.10张处方（=0.011），每周趋势变化为增加2.31张处方（<0.001），发出安全警告（I3）后，每周下降趋势变化为-2.09张处方（=0.007）。尽管NCP的IRF处方减少，但这些干预措施对标签外处方显示出适度且短暂的效果。我们的结果呼吁对解决不适当阿片类药物使用的安全干预措施的设计和实施进行审查。
