REMS problems need to be straightened out by FDA, industry

IT and other solutions are needed

Pharmacy directors across the nation already have identified some problems with the FDA's Risk Evaluation and Mitigation Strategy (REMS) process as announced in the last year.

Here are the issues several experts have identified:

• Consistent name for REMS programs: From a hospital pharmacist's perspective, a big pet peeve is the way pharmaceutical companies have labeled their REMS programs, says Bonnie Kirschenbaum, MS, FASHP, FCSHP, a health care consultant in Breckenridge, CO.

"Pharmaceutical companies are notorious for putting cutesy names on things," she says. "Many times when a pharmaceutical company has a REMS program, they never say 'REMS.'"

For example, Amgen Inc. and Centocor Ortho Biotech have implemented a REMS program for their erythropoiesis-stimulating agents (ESAs), calling it "APPRISE," which stands for Assisting Providers and cancer Patients with Risk Information for the Safe use of ESAs. It's an oncology program for cancer patients who are treated with one of the ESAs, including darbepoetin alfa (Aranesp®) and epoetin alfa (Epogen®, Procrit®).

This has helped confuse the issue for hospital pharmacies, she adds.

"I think if the pharmaceutical industry were more upfront in talking about REMS requirements it would help ease some of the confusion," Kirschenbaum says.

• Lack of technological integration: "Right now, none of the computer systems has a mechanism for REMS to track data," says Ernest R. Anderson, Jr., MS, FASHP, system vice president of pharmacy at Caritas Christi Healthcare System in Brighton, MA.

"One of our requests to the information technology arena is to ask vendors to build REMS into their software," Anderson says.

"Right now, it's a paper, manual process, or we have to create our own database in Excel," he adds. "Ideally, it would be great to have a pharmacy computer system that would allow pharmacists to see whether a particular physician is authorized to prescribe that medication, and it could notify you if there's a problem."

Health care technology companies should help health systems put REMS in the computer master system or provide a database file that holds the information, Kirschenbaum suggests.

• Restricted drug distribution and specialty pharmacies: "One of the biggest [REMS] frustrations that's starting to occur right now is the need for using a restricted drug distribution or a specialty pharmacy," Kirschenbaum says.

Some medications on the REMS list are very expensive and fall into the category of drugs that health payers put into a separate payment tier where the copay might be 25%-30% of the cost of the medication, she explains.

"And they require you to obtain the drug from a specialty pharmacy," she says.

The problem is that the hospital has a prohibition against patients using their medications brought from home. But if a patient has already paid that large copay for an expensive drug, he or she will not want to repay that copay for a prescription of the same drug to be taken while in the hospital.

Plus the insurance company won't pay for the drug twice. This leaves the hospital and hospital pharmacist in the hand-wringing position of trying to figure out how to get the medication to the patient, Kirschenbaum says.

Then when the medications are on the REMS list, the issue is even more complex.

"Now you have a drug with REMS requirements, and you have to deal with a specialty pharmacy," Kirschenbaum says.

A few hospitals will have their own specialty pharmacies and can handle it that way. But others might have to seek a complicated solution, such as "white-bagging" the drug. This might involve contacting the specialty pharmacy and having the medication shipped directly to the hospital pharmacy where it will be labeled and kept in a cubby for that one particular patient, she explains.

"Each time the shipment comes in for a patient, you're responsible for sorting and tracking the drug," she adds. "And if the patient doesn't use the medication anymore then you are left with the bag of medication that can't be used for anyone else, and you have to dispose of it."