Journal Article

Assessment of the FDA Risk Evaluation and Mitigation Strategy for transmucosal immediate-release fentanyl products.

Rollman JE; Heyward J; Olson L; Lurie P; Sharfstein J; Alexander GC.

Researchers assessed the effectiveness of the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy in preventing inappropriate prescribing of transmucosal immediate-release fentanyl, high-risk opioid products with narrow prescribing indications. Survey data obtained from patients, providers, and pharmacists at various points after the FDA program's initiation suggested ongoing misunderstanding regarding appropriate prescribing. Analysis of claims data 5 years into the program revealed that anywhere from 35% to 55% of patients were prescribed transmucosal immediate-release fentanyl products inappropriately.