Development of federally mandated risk evaluation and mitigation strategies (REMS) for transmucosal immediate-release fentanyl products

In the Know published on July 19, 2013 in REMS
Pain Pract. 2013 Apr;13(4):259-63. doi: 10.1111/papr.12040. Epub 2013 Mar 6.

Pergolizzi JV, Gharibo CG, Gudin JA, Nalamachu SR.


The FDA’s efforts to devise a strategy aimed at mitigating deleterious consequences from the inappropriate or nonmedical uses of TIRF products and other prescription opioids are commendable. Unfortunately, there is an incomplete understanding about how legitimate prescribing practices contribute to nonmedical analgesic use. The goal of reducing abuse, misuse, addiction, and overdose deaths, balanced against the potential for exacerbating untreated or poorly treated pain, must remain a central imperative to the process of REMS development, as the FDA itself has recognized. The complexity of this goal is such that it cannot be achieved in isolation. A multiagency intervention seems prudent and justified, especially given the national public concern related to prescription opioid nonmedical use and diversion. Collaboration among the key stakeholders, including the FDA, the DEA, the Centers for Disease Control and Prevention, the Substance Abuse and Mental Health Services Administration, the Federation of State Medical Boards, individual state and local healthcare regulatory and law enforcement agencies, prescribers, pharmacies, patient advocacy groups, and product manufacturers, has the potential to improve appropriate prescribing of opioids while helping to mitigate the risks of abuse and misuse. The literature supports the need for a comprehensive solution to the complex problems of nonmedical use and overdose with opioids. The new shared TIRF REMS program may be an important first step toward this goal, but it is likely that additional measures will be needed in the future.

PMID: 23464790 [PubMed - in process] View here
Last modified: June 3, 2013
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