Department of Clinical Pharmacy, School of Pharmacy, University of California San Francisco, San Francisco, CA, USA.
Medication Outcomes Center, University of California San Francisco, 521 Parnassus Ave, San Francisco, CA, 94143, USA.
Drug Saf. 2022 Apr;45(4):359-367. doi: 10.1007/s40264-022-01171-6. Epub 2022 Mar 17.
Shortages of opioid analgesics critically disrupt clinical practice and are detrimental to patient safety. There is a dearth of studies assessing the safety implications of drug shortages.
We aimed to assess perioperative opioid analgesic use and related postoperative hypoxemia (oxygen saturation less than 90%) in surgical patients exposed to prescription opioid shortages compared to propensity score-matched patients non-exposed to opioid shortages.
We conducted a retrospective study including adult patients who underwent elective surgery at The University of California San Francisco in the period August 2018-December 2019. We conducted a Gamma log-link generalized linear model to assess the effect of shortages on perioperative use of opioids and a weighted logistic regression to assess the likelihood of experiencing postoperative hypoxemia.
There were 1119 patients exposed to opioid shortages and 2787 matched non-exposed patients. After full matching, patients exposed to shortages used a greater mean of morphine milligram equivalents/day (146.94; 95% confidence interval 123.96-174.16) than non-exposed patients (117.92; 95% confidence interval 100.48-138.38; p = 0.0001). The estimated effect was a 1.25 (95% confidence interval 1.12-1.40; p = 0.0001) times greater use of opioids in patients exposed to opioid shortages than non-exposed patients. After full matching, a greater proportion of patients exposed to shortages (19.06%) experienced hypoxemia compared with non-exposed patients (16.91%). In addition, a greater proportion of patients exposed to opioid shortages (1.20%) experienced hypoxemia reversed by intravenous naloxone administration compared with non-exposed patients (0.44%).
Given the shortage prevalence, reliance on opioid medications, and related risk of respiratory depression, harm prevention measures remain critical to prevent postoperative complications that may compromise patients' safety.
阿片类镇痛药短缺严重扰乱了临床实践,对患者安全造成不利影响。目前评估药物短缺对安全性影响的研究甚少。
我们旨在评估与未暴露于阿片类药物短缺的患者相比,接受处方阿片类药物短缺的手术患者的围手术期阿片类药物使用情况和相关术后低氧血症(氧饱和度低于 90%)。
我们进行了一项回顾性研究,纳入 2018 年 8 月至 2019 年 12 月在加利福尼亚大学旧金山分校接受择期手术的成年患者。我们使用伽马对数链接广义线性模型评估短缺对围手术期使用阿片类药物的影响,并使用加权逻辑回归评估术后低氧血症的可能性。
共有 1119 名患者暴露于阿片类药物短缺,2787 名匹配的未暴露患者。完全匹配后,暴露于短缺的患者平均每天使用更多的吗啡毫克当量(146.94;95%置信区间 123.96-174.16)比未暴露患者(117.92;95%置信区间 100.48-138.38;p=0.0001)。估计的影响是暴露于阿片类药物短缺的患者使用阿片类药物的可能性增加 1.25 倍(95%置信区间 1.12-1.40;p=0.0001)。完全匹配后,暴露于短缺的患者发生低氧血症的比例(19.06%)高于未暴露患者(16.91%)。此外,暴露于阿片类药物短缺的患者发生需要静脉注射纳洛酮逆转的低氧血症的比例(1.20%)高于未暴露患者(0.44%)。
鉴于短缺的普遍存在、对阿片类药物的依赖以及相关的呼吸抑制风险,防止术后并发症的危害预防措施仍然至关重要,以保护患者的安全。