Study Finds Inadequate Regulatory Oversight
Despite the existence of stringent regulatory controls, clinicians are prescribing potentially lethal fentanyl products to patients who should not be receiving them. So concludes a study from the Johns Hopkins Bloomberg School of Public Health published earlier this week in the Journal of the American Medical Association. The study focused on prescribing patterns for transmucosal immediate release fentanyls (TIRFs) during 2012 to 2017. Due to their high potency and rapid onset of action, TIRFs are FDA approved for adult cancer patients “who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.” A Risk Evaluation and Mitigation Strategy (REMS) program was initiated by FDA in 2011, that includes a “closed distribution system” requiring TIRF makers to demonstrate compliance via annually submitted reports. But senior author G. Caleb Alexander, MD, stated, “Despite the use of what should have been a very stringent monitoring program on the part of the FDA and TIRF makers, we found widespread TIRF use by patients for which the products had an absolute contraindication.”
The researchers found an escalating incidence of inappropriate prescribing of TIRF products over the span of the study period. In their 2016 annual submission to FDA under the REMS program, TIRF makers were reporting that between 34.6% and 55.4% of TIRF prescriptions were to patients who lacked opioid tolerance. TIRF makers were supposed to identify, investigate, and disenroll noncompliant prescribers under the terms of the REMS program, but the researchers found no instances of such action during the study period. Dr. Alexander continued, “The FDA and the TIRF manufacturers overly relied on surveys and failed to build a program from the ground up to prevent inappropriate TIRF use. They also missed important opportunities to make substantive revisions to the program even as alarm bells were sounding.”
To read more about fentanyl, click here.
Read about the study.
The journal abstract may be read here.
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