Reduction in Medication Errors: The Fentora Case Study

Fentora (fentanyl citrate) is an analgesic opioid used in the management of breakthrough pain in adult cancer patients. Numerous reports of medication errors had been reported since the product's launch in 2006, 74% of which were prescribing errors. Subsequent to the initiation of a risk evaluation and mitigation strategy (REMS) by FDA and the sponsor in 2011, reports of prescribing errors dropped rapidly. It is likely the REMS had a significant impact on the safe use of this important product. While further data from subsequent years would be needed to confirm this hypothesis, this is one of the first reports of an FDA and industry cooperative effort that showed a rapid increase in the safe use of a marketed pharmaceutical product as result of a REMS program.