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Hospital pharmacy directors, staff will need to know and handle REMS
Focus on big picture, not complications
Hospital pharmacy directors can view REMS as a positive move forward in patient safety or as an unfunded mandate that will cost them valuable staff time. Either way, it's certain they'll need to move REMS to the top of their priority list.
As part of the Food and Drug Administration Amendments Act of 2007, the FDA requires a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. There are 111 products with REMS requirements.
"The intent of REMS is to allow the FDA to approve drugs faster and get them to market faster because they will be monitoring the safety of drugs once they're approved and used by patients," says Ernest R. Anderson, Jr., MS, FASHP, system vice president of pharmacy at Caritas Christi Healthcare System in Brighton, MA. Anderson has spoken at national conferences about REMS, including discussing REMS at the 2010 American Society of Health-System Pharmacists (ASHP) summer meeting and exposition, held in Tampa, FL, June 6-9, 2010.
The FDA amendment resulting in REMS came about because of a series of drug recalls in which drugs were found to have serious adverse events that led to their withdrawal from the market, Anderson adds.
The most notorious example is rofecoxib (Vioxx®), the nonsteroidal anti-inflammatory drug (NSAID) that was approved by the FDA in 1999, and resulted in billions of dollars in sales for Merck before it was withdrawn from the market in 2004 due to safety issues associated with increased risk of heart attack and stroke after long-term, high-dosage use.
REMS puts postmarketing safety monitoring and measures in place to prevent future problems of that kind.
Unfunded mandate or patient safety improvement?
"This is the FDA's attempt to provide drugs to the marketplace in a more rapid fashion, but to also have safety monitors in place," he says.
The drawback is that it increases the workload for hospital pharmacies, physicians, and others.
"It's an unfunded mandate, and we have to do it," says Philip E. Johnson, MS, RPh, FASHP, a pharmacy advocacy director at H. Lee Moffitt Cancer Center in Tampa, FL. Johnson spoke at the ASHP summer meeting about REMS.
"It takes a lot of work, and we won't be reimbursed for it, so it will take away our time from patients," Johnson adds.
"REMS is one of the most wonderful safety concepts the FDA has come up with," says Bonnie Kirschenbaum, MS, FASHP, FCSHP, a health care consultant in Breckenridge, CO. Kirschenbaum also was an expert on a REMS panel at the ASHP summer meeting.
Drugs under development that have safety concerns and some existing drugs with continued safety issues are handled through REMS. The process requires the involvement of prescribers, pharmacists, pharmaceutical companies, and patients.
"For new drugs on the market this saves years and years of further testing to try to get experiential data on potential safety issues with the product," Kirschenbaum says.
Two examples of drugs that recently came to market with REMS requirements are injectable romiplostim (Nplate®) to treat chronic immune thrombocytopenic purpura (ITP) and dofetilide (Tikosyn®), an antiarrhythmic used in the treatment of atrial arrhythmias, she says.
"In phase III clinical testing that happens before the drug is approved, it was decided those drugs would benefit by having REMS," she adds.
The class of drugs that might most concern pharmacists and physicians right now are the erythropoiesis-stimulating agents (ESAs), including epoetin alfa (Epogen®, Procrit®) and darbepoetin alfa (Aranesp®), Kirschenbaum notes.
ESAs are the first class of drugs for which all products must have REMS.
"So whoever makes an ESA has to abide by this, and they have to be identical to all the products in the class," Kirschenbaum says. "Two manufacturers have to work together."
One reason why the ESAs are a big change is because these are a good example of drugs that have been on the market for a long time but only recently have been identified as drugs that have some safety issues that require REMS, she adds.
Later this summer there will be another big REMS addition when the long-acting opioids are added to the list, she notes.
ESAs are the first big REMS program that hospitals will have to handle, and they have one year to comply with REMS requirements for ESAs, Johnson says.
"This only went into effect in March," he adds.
Many experts question the FDA's ability to handle REMS data, and they fear the FDA won't achieve its stated goal of getting drugs to market faster and safer, Johnson says.
"People are confused, and data on a population of 150 physicians show that people don't know what's required, and they're inconsistent in implementing the REMS programs," Johnson says.
The FDA might have accomplished even more if it had built drug safety into the whole review process rather than separating it. But since REMS is the requirement, pharmacists and others should work with the FDA to get all stakeholders involved and to collaborate to make the process better, he adds.
"We need standardized forms and languages so that patients really understand them and so the processes are the same," Johnson says. "Right now each REMS program is totally different."
For instance, some REMS programs require manufacturer-provided education for patients, and others require physicians to be certified through an education program. With some drugs, patients have to sign an informed consent form every time they receive the REMS drug.
One issue that troubles pharmacists and others is the requirement that the language for some REMS medications include the warning that the drug could contribute to the patient's death.
The potential for the drug causing death is based on inappropriate use of the drug and not on the drug's danger if used the way it's supposed to be used, Johnson says.
"The patient's informed consent is not very user friendly," he adds.
When the National Comprehensive Cancer Network (NCCN) met in May 2010, there were several patient advocacy groups that spoke out strongly about the REMS informed consent language, wording, and balance, he notes.
"REMS is focusing only on risk, and it's not a balanced approach," Johnson says.