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

Abstract

Opioid analgesics, including transmucosal immediate-release fentanyl (TIRF) products, are associated with serious risks of abuse, addiction, and overdose. In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA), requiring manufacturers to implement a Risk Evaluation and Mitigation Strategy (REMS) for opioid distribution. In 2009, recommendations for “Elements to Assure Safe Use” (ETASU) were released. In March 2012, a shared TIRF-REMS program (http://www.tirfremsaccess.com) was implemented; the shared TIRF-REMS was modeled in part on a separate REMS program for sublingual TIRF tablets. The goals of the shared TIRF-REMS program are to “mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors.” These goals were designed to limit dispensing to appropriate patients, prevent inappropriate conversion between fentanyl products, avoid accidental exposure, and educate about risks. The shared TIRF-REMS program is controlled by a limited-access distribution system that mandates enrollment and certification of prescribers, pharmacies, distributors, and patients. Clinicians who prescribe TIRF products to outpatients must meet several ETASU requirements, including reviewing educational materials and completing a Prescriber Knowledge Assessment (https://www.tirfremsaccess.com/TirfUI/rems/education.action) and Prescriber Enrollment Form (https://www.tirfremsaccess.com/TirfUI/rems/pdf/prescriber-enrollment-form.pdf). A Patient-Prescriber Agreement Form (https://www.tirfremsaccess.com/TirfUI/rems/pdf/ppaf-form.pdf) must be submitted within 10 days from prescription processing; only 3 prescriptions can be written until the form is received. Form renewals are required every 2 years. Pharmacies distributing TIRF products must meet specific guidelines, including designating a pharmacist to be responsible for a pharmacy management system that supports communication with the TIRF-REMS program; however, pharmacies dispensing TIRF products solely to inpatients only need to be certified. Although the shared TIRF-REMS program is an important step toward the FDAAA goals, it is likely that additional measures will be needed, including procedures to control non-prescription opioid misuse and abuse. Supported by ProStrakan. Opioid analgesics, including transmucosal immediate-release fentanyl (TIRF) products, are associated with serious risks of abuse, addiction, and overdose. In 2007, Congress passed the Food and Drug Administration Amendments Act (FDAAA), requiring manufacturers to implement a Risk Evaluation and Mitigation Strategy (REMS) for opioid distribution. In 2009, recommendations for “Elements to Assure Safe Use” (ETASU) were released. In March 2012, a shared TIRF-REMS program (http://www.tirfremsaccess.com) was implemented; the shared TIRF-REMS was modeled in part on a separate REMS program for sublingual TIRF tablets. The goals of the shared TIRF-REMS program are to “mitigate the risk of misuse, abuse, addiction, overdose and serious complications due to medication errors.” These goals were designed to limit dispensing to appropriate patients, prevent inappropriate conversion between fentanyl products, avoid accidental exposure, and educate about risks. The shared TIRF-REMS program is controlled by a limited-access distribution system that mandates enrollment and certification of prescribers, pharmacies, distributors, and patients. Clinicians who prescribe TIRF products to outpatients must meet several ETASU requirements, including reviewing educational materials and completing a Prescriber Knowledge Assessment (https://www.tirfremsaccess.com/TirfUI/rems/education.action) and Prescriber Enrollment Form (https://www.tirfremsaccess.com/TirfUI/rems/pdf/prescriber-enrollment-form.pdf). A Patient-Prescriber Agreement Form (https://www.tirfremsaccess.com/TirfUI/rems/pdf/ppaf-form.pdf) must be submitted within 10 days from prescription processing; only 3 prescriptions can be written until the form is received. Form renewals are required every 2 years. Pharmacies distributing TIRF products must meet specific guidelines, including designating a pharmacist to be responsible for a pharmacy management system that supports communication with the TIRF-REMS program; however, pharmacies dispensing TIRF products solely to inpatients only need to be certified. Although the shared TIRF-REMS program is an important step toward the FDAAA goals, it is likely that additional measures will be needed, including procedures to control non-prescription opioid misuse and abuse. Supported by ProStrakan.