Fallon anticipates this confusion may be a particularly big challenge for patients who are simultaneously using a number of other medications. Physicians will also feel the effect of the growing number of drugs with a REMS, says Dr. Bello, who represented the ACR at a meeting between the American Medical Association and key FDA stakeholders.
“We understand there should be some control of these medications. The question is how to implement these controls,” he says. For example, there has been talk of requiring special training or certification before physicians could prescribe certain opioids. “Not all physicians want to do that training or have the time to do it,” he says. Consequently, they may not prescribe those drugs to patients who really need them—or, they may refer those patients to other physicians who have that training, thereby taking up extra seats in the waiting room at those physicians’ offices.
REMS and increased restrictions on medications such as opioids could also push physicians to instead prescribe other medications that are not as effective or that are used off-label, say Fallon and Dr. Bello. “It’s like a balloon,” Dr. Bello says. “If you squeeze one side, the other side gets bigger.”
One wrinkle for rheumatologists is how they will manage patients who may use REMS drugs that were prescribed by other physicians. “We inherit patients on these medications, but what do we know about them?” Dr. Bello says.
Better training on medications such as opioids or other drugs that have or will require a REMS is needed in rheumatology—preferably in preexisting CME venues, Dr. Bello says. The ACR and other organizations have done a solid job on this front with biologic agents since the Vioxx controversy, he believes.
Fallon believes that pharmacists will also have to play a stronger role in patient education. “We have to think of a better system,” she says. “It may be a combination of education from the clinic and the pharmacy.”
Vanessa Caceres is a medical writer and editor in Florida.
- Food and Drug Administration. Questions and answers on the federal register notice on drugs and biological products deemed to have risk evaluation and mitigation strategies. Available online at www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/ucm095439.htm. Created March 26, 2008; updated March 27, 2008; accessed July 9, 2009.