By Edward C. Li, PharmD, BCOP, NCCN eBulletin Drugs & Biologics Editor, and Kathryn Barker, NCCN Staff
In response to recent Food and Drug Administration (FDA) actions, NCCN has created spaces on both NCCN.org and NCCN.com to serve as reference tools for clinicians and patients seeking more information about drugs requiring Risk Evaluation and Mitigation Strategies (REMS). REMS are strategies intended to assess adverse risks associated with particular drugs and biologics. These types of analyses, which traditionally fell under the jurisdiction of private sponsors and companies, are now coming to drug manufacturers in the form of FDA mandates.
The current REMS clinician page at NCCN.org lists agents used in oncology care that now require REMS, including both agents for active treatment and those used for supportive care. On NCCN.com, the REMS patient page describes what these regulations mean for patients and consumers, such as requirements that may oblige patients to participate in educational programs, to provide documentation related to lab or test results, to enroll in a patient registry, or to participate in additional monitoring during treatment with an agent that requires REMS.
The specific strategy a REMS program employs will vary, but may include providing a medication guide, a patient package insert, a communication plan, elements to assure safe use, and an implementation system. All REMS programs must contain a timetable for assessment.[i] These programs and supplements hold significance for oncologic practitioners and patients alike. As a result of tightened regulations, it is anticipated that many prescribers will need to accrue further training or accreditation in order to secure the right to prescribe certain medications. Additionally, they may be required to monitor or to enroll patients through registry programs or other methods. The REMS program also has implications for pharmacists and pharmacies. Pharmacists will likely have to complete educational programs or comply with certain procedural changes in order to attain the necessary certification to dispense particular medications.
The FDA reserved the right to order REMS as of March 25, 2008 by way of the Food and Drug Administration Amendments Act of 2007 (FDAAA). REMS are issued by the FDA for certain drugs and biologics the agency believes require a mechanism to ensure that the benefits outweigh the risks for patients. This applies mainly to new drug applications, but can be applied retroactively to existing approved medicines. Manufacturers for which REMS are mandated are asked to create systematic plans that can be used both to educate patients and healthcare providers about risks associated with particular medications, and to simultaneously work to minimize those risks through various organizational and provisional adjustments.
The REMS concept is not new to the oncology field. Some oncologic drug manufacturers were among the first companies that issued REMS. For example, physicians, pharmacies, and patients that plan to prescribe, dispense, or receive thalidomide must enroll in the S.T.E.P.S.® program employed by Celgene Corporation. Because of new regulations, it is likely that more REMS programs will follow. In February 2009, the FDA announced that 16 drug makers will be required to submit REMS for medications containing opioids.[ii] Most of the affected products contain morphine, fentanyl, oxycodone or methadone. These REMS have been ordered to minimize the widespread and high-risk abuse of prescription pain killers. Resulting from the effort to ensure that only those who display legitimate need for these medications will have access to them, it is likely that health care providers and patients in the field of oncology will soon be required to submit to changing and heightened standards in order to prescribe and obtain these drugs.
NCCN is working to serve the clinicians and patients who may be affected by these REMS changes by providing an online page where drug manufacturers can place direct links to their specific REMS programs. These will contain educational information pertinent to clinicians or patients looking to prescribe, dispense or receive the medicine. Furthermore, for the education and convenience of visitors, medications and their corresponding REMS programs will be organized by the disease or the area of care that they pertain to. Through this structured compilation of program links, NCCN will provide comprehensive and clear answers for patients and clinicians who may be wondering what sort of ramifications REMS carry for them. This one stop cache of information is a valuable resource for oncologic patients and healthcare providers concerned about the safety and availability of the medications that they need.
[i]Questions and Answers on the Federal Register Notice on Drugs and Biological Products Deemed to Have Risk Evaluation and Mitigation Strategies. Federal Register Notice. March 26, 2008. Available from: The Food and Drug Administration. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/
SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm095439.htm. Accessed June 10, 2009.
[ii] FDA Seeks REMS for Opioid Painkiller Products. FDAnews Drug Daily Bulletin. February 11,2009; 6:28. Available from: The Food and Drug Administration. http://www.fdanews.com/newsletter/article?issueId=12386&articleId=114481. Accessed June 10, 2009.