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Revised REMS for transmucosal immediate release fentanyl preparations

For patients with chronic cancer-related pain who are receiving long-acting opioids, breakthrough pain may be targeted with one of the newer rapid-onset, transmucosal immediate release fentanyl (TIRF) formulations, which are specifically indicated for opioid-tolerant cancer patients. In the United States, all of these products, including generics, have a mandatory shared risk evaluation and mitigation strategy, the purpose of which is to reduce the risk of misuse and unintentional overdose. Because of data suggesting that TIRF preparations are still being prescribed to opioid-naïve patients, additional regulations have been put into place by the U.S. Food and Drug Administration, requiring that opioid tolerance be verified and documented by both the prescriber and the outpatient pharmacy, prior to each individual TIRF prescription [1].

Use of fascial plane thoracic nerve blocks for multimodal analgesia after cardiac surgery

Fascial plane thoracic nerve blocks of the anterolateral chest wall can be used as part of a multimodal approach to postoperative analgesia in cardiac surgical patients. In a 2020 systematic review of mostly observational studies and including over 600 patients, heterogenous data suggested that use of a single-injection serratus anterior plane (SAP) or pectoral nerves (PECs) block reduced pain scores and opioid consumption for 6 to 12 hours after cardiothoracic surgery [2]. We employ such regional nerve blocks for cardiothoracic surgery given the relative ease of placement and absence of the side effects associated with neuraxial analgesia (eg, epidural or spinal techniques).


FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs. Available at: https://www.fda.gov/news-events/press-announcements/fda-takes-further-steps-confront-opioid-crisis-through-risk-evaluation-and-mitigation-strategy (Accessed on January 04, 2021).
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The role of serratus anterior plane and pectoral nerves blocks in cardiac surgery, thoracic surgery and trauma: a qualitative systematic review

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