1. After 5 years of monitoring, the Risk Evaluation and Mitigation Strategy (REMS) program found that up to half of opioid non-tolerant patients were being inappropriately prescribed transmucosal immediate-release fentanyl products.
2. While the REMS program had a noncompliance plan, after 5 years there was no evidence of any prescriber being unenrolled for inappropriate prescribing nor the FDA making substantial changes to the program.
Evidence Rating Level: 2 (Good)
Study Rundown: Formed in 2007, the aim of the Risk Evaluation and Mitigation Strategy (REMS) program is to support the appropriate use of prescription medications. In 2011, this program implemented a highly restrictive policy regarding transmucosal immediate-release fentanyl products (TIRFs) that sought to avoid prescribing TIRFs to opioid non-tolerant patients and support appropriate prescribing of TIRFs when indicated. After obtaining documents via the Freedom of Information Act (FOIA), this study reviewed the effectiveness of this program. Despite widespread acknowledgment by prescribers that TIRFs are FDA-approved for breakthrough cancer pain in opiate-tolerant patients, up to half of patients being prescribed TIRFs were opioid non-tolerant. There was a lack of understanding among prescribers, pharmacists, and patients where many believed TIRFs were FDA-approved for chronic, noncancer pain. Additionally, while the REMS program had a noncompliance policy to deactivate prescribers who inappropriately prescribed TIRFs, over the course of 5 years, there was no evidence of any prescriber being unenrolled. Thus, at the 5-year assessment the FDA concluded that the REMS program was not meeting its overall goal or objectives in limiting TIRF use to opioid-tolerant patients with breakthrough cancer pain. However, no substantial changes were made to this program.
With the growing rate of opioid overdose related deaths in the United States and the rapid increases in opioid abuse disorder, preventing TIRFs from being inappropriately prescribed should be of upmost importance. While survey-based data demonstrated a high level of knowledge regarding the appropriate prescribing of TIRF medications, claims-based data still shows a high level of inappropriate prescribing. Thus with these results of the REMS program assessment, further changes should be implemented to maximize the appropriate prescribing of TIRFs.
In-Depth [retrospective cohort]: In this study, 3,812 pages of materials related to the FDA’s TIRF REMS program were obtained via the FOIA. The objectives of the program were to avoid prescribing TIRFs to opioid non-tolerant patients and to support appropriate prescribing of TIRFs when indicated. The documents originated from 2012 to 2017 and were reviewed in January 2018 with the aim of determining the knowledge and attitudes of patients (n= 192), prescribers (n= 302), and pharmacists (n= 302). Additionally, the documents contained survey- and claims-based prescribing assessments. At the 5-year report, the REMS program found that between 34.6% and 55.4% of opioid non-tolerant patients were being prescribed TIRFs. At the same time, survey-based data revealed that only 50.9% (n= 162) of pharmacists reported that TIRFS should not be prescribed for chronic, noncancer pain. Additionally, 18.4% (n= 54) of prescribers and 47.7% (n= 148) of patients reported that TIRFs are FDA-approved for chronic, noncancer pain. The REMS program does have a noncompliance plan where it sought to deactivate prescribers for inappropriate prescribing of TIRFs, however, after 5 years, there was no evidence of any prescriber being unenrolled and no substantial changes made to the program by the FDA.
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