Assessment of prior opioid tolerance among new users of fentanyl transdermal system in FDA's Sentinel System

Abstract

Purpose Fentanyl transdermal system (FTS) is intended only for patients with prior opioid tolerance. The purpose of this study is to identify the proportion of new FTS users who had evidence of prior opioid tolerance, by dosage strength, in FDA's Sentinel System. Methods We identified new FTS episodes (183‐day washout) from 2009 through 2013. Members were <65 years and enrolled in medical and pharmacy coverage for 183 days prior to initial FTS dispensing (index). We assessed the proportion of users with prior tolerance stratified by dosage strength of FTS using four definitions of opioid tolerance: ≥30‐mg oxycodone equivalents/day in each of 7 consecutive days immediately prior to index; ≥30‐mg oxycodone equivalents/day for any 7 days in the 30 days prior to index (secondary); any dose in each of 7 days in the 7 consecutive days immediately prior to index (tertiary); and any dose for any 7 days in the 30 days prior to index (quaternary). Results Of 44 450 episodes of 25 mcg/hr FTS, 37% met the primary definition, and 77% met the quaternary definition. Of 3507 episodes of 100 mcg/hr FTS, 57% and 74% met the primary and quaternary definitions, respectively. Those aged 25 to 34 years had the highest proportion of episodes with prior tolerance; those aged 55 to 64 accounted for more of the episodes overall. Conclusions In Sentinel, many new users of FTS did not have evidence of prior opioid tolerance by the primary definition, ie, the product label definition, which is the minimum standard for the lowest FTS dose (12 mcg/hr), especially at the highest strength (100 mcg/hr). Validation of this metric is warranted, but our findings suggest the need for further prescriber education regarding appropriate prescribing of FTS.

Perioperative analgesic efficacy and adverse events of fentanyl in dentistry: A systematic review

“…The use of a transdermal fentanyl patch to relieve acute postoperative pain is not advised, and any patient undergoing surgery should have the fentanyl patch removed prior to surgery (Kaye et al., 2019). It has also been stated that the fentanyl transdermal system is a prolonged release opioid analgesic formulation intended only for patients with past opioid tolerance; this restriction concerns to all prescriptions (Cocoros et al., 2019).…”

“…In cases of severe dental trauma resulting from accidents or injuries, where patients experience intense pain, fentanyl may be also considered to provide rapid and effective pain relief (Marchand & Argáez, 2021). Some individuals may have a heightened sensitivity to pain or underlying medical conditions that make them more resistant to standard pain medications, thus, fentanyl may be used in these cases to ensure adequate pain control (Cocoros et al., 2019). Besides, there are reports of other uses for pain management in oral mucositis (Demarosi et al., 2004), oral submucous fibrosis (Nihadha et al., 2022), postsurgical pain management in jaw cancer (Dhasmana et al., 2009) and pulpal analgesia (Uhle et al., 1997), among others.…”

“…Another study, which evaluated the understanding of fentanyl usage among pharmacists, prescribers, and patients, reported significant instances of improper use (Rollman et al., 2019). Furthermore, other findings indicated the necessity for additional education among prescribers concerning the proper prescription of fentanyl (Cocoros et al., 2019).…”

Comparing Patient-Controlled Analgesia Versus Non-PCA Hydromorphone Titration for Severe Cancer Pain: A Randomized Phase III Trial

“…Opioid tolerance was defined as having received a $25 mcg/h fentanyl patch, $60 mg oral morphine daily, $30 mg oral oxycodone daily, or an equianalgesic dose of another opioid for $1 week. 3,8,10,25,26 The protocol was approved by the central ethics committee of the Fujian Cancer Hospital and local ethics committees of all participating hospitals. All participants provided written informed consent.…”