Pharmacists, prescribers, and patients tend to have adequate knowledge of transmucosal immediate-release fentanyls (TIRFs) for use in breakthrough cancer pain, according to a study published in JAMA.
The US Food and Drug Administration (FDA) has been using Risk Evaluation and Mitigation Strategies (REMS) since 2007 in an effort to promote safe use of prescription medications. Researchers performed a qualitative analysis of 4877 pages from FDA documents obtained under the Freedom of Information Act. Pages related to the TIRF REMS program and annual REMS assessment reports published between 2012 and 2017, as well as FDA evaluations of REMS assessment reports and FDA-sponsor correspondence regarding safety issues were examined. The investigators sought to assess the efficacy of the REMS program in reducing the risk for TIRF-related adverse outcomes (ie, misuse, abuse, addiction, and overdose). They also evaluated TIRF knowledge among pharmacists, prescribers, and patients.
At 12 months after REMS initiation, the prevalence of incorrect reporting that TIRFs can be prescribed to patients not tolerant to opioids was 7.9%, 11.6%, and 2.6% among pharmacists, prescribers, and patients, respectively. After 60 months of program initiation, between 34.6% and 55.4% of patients who were considered nontolerant to opioids were prescribed TIRFs. Approximately 34% of prescribers reported prescribing TIRFs to opioid-tolerant patients with chronic noncancer pain 48 months following program initiation. Up to 47.7% of patients and 18.4% of prescribers incorrectly reported that TIRFs were approved by the FDA for chronic noncancer main 60 months after REMS initiation.
Study limitations include the lack of data on the potential burdens of the REMS program, and in particular, the burden on prescribers, patients, and pharmacists.
“Despite these findings, the FDA did not require substantive changes to the program,” noted the study authors.
Rollman JE, Heyward J, Olson L, Lurie P, Sharfstein J, Alexander GC. Assessment of the FDA risk evaluation and mitigation strategy for transmucosal immediate-release fentanyl products. JAMA. 2019;321(7):676-685.