• A communication plan is another element of REMS and is a means of providing education on the safe and appropriate use of pharmaceutical products to health care providers. A communication plan is implemented by the manufacturer and involves contacting healthcare providers or professional societies, usually via letters, to encourage compliance with the REMS elements.
• An ETASU may be required as parts of REMS if the FDA determines the other elements are incapable of guaranteeing the safe use of the medication. An ETASU may involve attainment of special certification of prescribers and pharmacies that are involved with the dispensing of these pharmaceutical products, or may restrict the use of these medications only to patients who are enrolled in registries, receive treatment in specific settings or with documentation of certain safety requirements.
In transplantation, the costimulation inhibitor, belatacept (Nulojix®), has required a medication guide and a communication plan for its REMS since June 2011. In September 2012, the mycophenolic acid derivatives (mycophenolate mofetil [CellCept®] and its generic products and enteric-coated mycophenolic acid [Myfortic®]), which are T-cell proliferation inhibitors, were issued a REMS requirement that included a medication guide and an ETASU. In general nephrology, there are REMS in place for the erythropoietin-stimulating agents (i.e. epoietin alfa [Epogen® and Procrit®], darbepoietin [Aranesp®] and peginesatide [Omentys®]). The REMS epoietin alfa products and darbepoietin each contain a medication guide, communication plan and ETASU. However, the ETASU is meant only for those patients using one of these agents for anemia associated with malignancy. The peginesatide REMS only contains a communication plan. It is vital for nephrologists to realize that there may be other medications that prescribe on a routine basis in your practice that contain a REMS, besides the ones listed above.
It is important to keep in mind that the overall goal of REMS is to increase patient safety in regards to the use of high-risk pharmaceutical products. The FDA tries to limit the burden that REMS puts on health care providers and patients. However, a result of REMS may be the decreased utilization of specific high-risk medications to avoid the REMS requirements . This is an unfortunate and unintended consequence of a program that was created to increase the safe and effective use of medications. The usage patterns of medications the FDA has determined require a medication guide, communication plan, or ETASU, should not be altered to avoid the extra work associated with these elements of REMS.
Sara Rostas, PharmD, PGY1 Pharmacy Practice Resident
Steven Gabardi PharmD, FCCP, BCPS, Organ Transplant Clinical Specialist