Table 2.

Examples of elements to assure safe use

Element	Drugs	Requirement (examples)
Documentation of safe use	Alvimopan (Entereg)	Dispensed only at hospitals that perform bowel resections, no more than 15 doses per patient
	Isotretinoin (Accutane (off market) and generic)	Negative pregnancy test, two documented forms of contraception (iPLEDGE)
	Lenalidomide (Revlimid) and all thalidomide analogs	Negative pregnancy tests
	Vigabatrin (Sabril)	Baseline ophthalmologic assessment within 4 weeks then every 3 months after
Prescriber training and/or certification	Buprenorphine/naloxone (Suboxone)	Complete course and certification
	Fentanyl transmucosal (Actiq, Fentora, and several others)	Pharmacy check prescriber certification with a sponsor database
	Erythropoiesis-stimulating agents (ESA): Aranesp (darbepoetin alfa); Epogen and Procrit (epoetin alfa)	Provider and hospital designee must complete training (APPRISE Oncology Program)
Safety monitoring	Olanzapine long-acting injection (Zyprexa Relprevv) Clozapine (Clozaril)	Continuous observation for 3 h post-injection (olanzapine) Complete blood count (clozapine)
Registries	Isotretinoin (generic only) Vigabatrin (Sabril)	iPLEDGE program SHARE program
Restricted distribution	Oxybate (Xyrem) Vigabatrin (Sabril)	Distribution from single national pharmacy (Xyrem)