How to prepare for REMS compliance

Do more work with no additional funding

Pharmacists will be closely involved with helping the FDA monitor the Risk Evaluation and Mitigation Strategy (REMS) as increasing numbers of drugs are added to the REMS list.

Their role will include registering sites, ensuring physician registration, ensuring patient registration, and submitting required data.

"This is an unfunded mandate, and what happens is pharmacy ends up being the gatekeeper for most of these programs," says Ernest R. Anderson, Jr., MS, FASHP, system vice president of pharmacy at Caritas Christi Healthcare System in Brighton, MA.

"Everyone looks to the pharmacy to make sure physicians are signed up, and if a certification date needs to be sent into the pharmaceutical company, then pharmacy is required to do that," he adds.

REMS requirements vary according to the drug, but the medications with the most required components include erythropoiesis-stimulating agents (ESAs), romiplostim (Nplate®), fentanyl buccal (Fentora), and vigabatrin.

"One of the simplest requirements is to create a medication guide," he says.

"REMS also can require a communication plan, and the more sophisticated REMS programs are where pharmacy, physicians, and patients all need to sign up for the program to receive the drug," Anderson adds. "Patients have to sign that they've been educated, and some require physicians to sign an attestation that they have gone through the training programs."

Anderson and other experts offer these tips on how to implement REMS programs:

• Utilize available online resources: The American Society of Health-System Pharmacists (ASHP) has a Risk Evaluation and Mitigation Strategies Resource Center that can be accessed at www.ashp.org/REMS. The website defines REMS and lists REMS drugs by generic name.

The FDA has information about REMS at the website: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.

The FDA's website includes information on the following:

- Draft Guidance on Risk Evaluation and Mitigation Strategies;

- Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications;

- Medication Guides;

- Drugs@FDA;

- Index to Drug-Specific Information.

Specific information about ESAs and REMS can be found at the website for Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESA's (APPRISE) at www.esa-apprise.com.

• Educate staff about REMS: It's important for pharmacy and other hospital staff to know that REMS will require a more involved process when they're handling certain medications.

"REMS still is a relatively new thing," Anderson says. "It was approved by the government in 2007, implemented in March 2008, and in 2009 some of these activities began."

So pharmacists only now are recognizing the need to be educated on REMS, he adds.

For most drugs on the REMS list, the process requires little more than providing patients with a medication guide the pharmaceutical company created, says Bonnie Kirschenbaum, MS, FASHP, FCSHP, a health care consultant in Breckenridge, CO.

"The FDA said that some drugs just need to have a message or warning for everyone to be vigilant, and that's in what they call 'medication guides,'" she says. "That's the simplest of the REMS requirements, but it's more complicated than the typical information for drugs."

For instance, the medication guide language often discusses how the medication might result in the patient dying, and that can be scary for patients, she explains.

"The medication guides are freely available and can be included in pharmacy dispensing systems when you enter in that prescription," Kirschenbaum says.

The next step is to provide both a medication guide and a communication plan.

"This communication plan is to inform the physician and prescriber that we're having a little extra vigilance with this drug," Kirschenbaum says.

Then, for a handful of drugs, there also will need to be elements to assure safe use (ETASU) and an implementation system. These certain drugs, including ESAs, will require prescribers to be certified, to complete a training program, and to attest to their doing so. Also, hospitals that dispense ESAs will need to be certified, and patients will need to sign an informed consent document that explains the risks and benefits of using the drug.

"There are not many drugs that require registration, but there's a concern that there will become more and more of these in the future," Anderson says.

Each REMS program has a different deadline, and the deadline for ESAs is for physicians to enroll by February 2011. Hospitals have to track physician enrollment.

Hospitals and providers who fail to enroll in the REMS program will have their access to the REMS drug suspended.

• Use the hospital pharmaceutical and therapeutics (P&T) committee: Hospitals can establish new committees to deal with REMS, but it would work fine if they simply brought REMS into their existing medication review process, Kirschenbaum says.

The hospital pharmacy should develop a mechanism for dealing with REMS through the P&T committee, she adds.

"Once you develop a mechanism it doesn't become an issue for every drug," she says. "When presenting to the P&T you present a monograph, so you can add REMS to it, asking if the drug requires REMS, and if the answer is 'yes' then this is how we're going to handle it."

Before adding REMS to the process, pharmacy should educate the P&T committee, as well as hospital physicians and other stakeholders about the process, suggests Philip E. Johnson, MS, RPh, FASHP, a pharmacy advocacy director at H. Lee Moffitt Cancer Center in Tampa, FL.

"The drug safety component should be part of the whole process and not a separate, distinct function," Johnson says. "So we're trying to build REMS into the whole process."

The P&T committee needs to understand what REMS is and how the information will be processed and monitored, he says.

"When a REMS drug is used for the patient, you need to make sure the patient is aware of it and that the proper REMS activities transpire," he adds. "Then it's a matter of keeping records and making sure you report everything you have to."

• Register pharmacists for REMS programs: Hospitals that dispense ESAs will need to be certified, a process that pharmacists should complete.

"If you go online you'll see four different sections on the APPRISE website, including a section for pharmacy," Anderson says. "Go through each one, and at the end it will give you a place to verify that you've read all the information and can attest that you'll pass this information on to prospective patients."

Once pharmacists complete the education program they can sign up the pharmacy to receive the drugs, he adds.

Each hospital pharmacy will need at least one pharmacist who has signed up for the program, but it'd be wise to have multiple pharmacists signed up, Anderson says.

"Every site at our health system is now signed up," he says. "And we're working to make sure physicians at each site are signed up too."

• Collect data on REMS drugs:"REMS information is collected by individual sites and sent to the FDA," Anderson says.

So far there is no standardization with data collection, which is a problem for many pharmacists.

Pharmaceutical companies are required to report information about REMS drug adverse events, and the FDA theoretically will use this information to monitor the drugs' safety.

It's possible that for some years after a REMS drug has been monitored, and if no safety issues are raised, that it will be dropped from the REMS list, Kirschenbaum says.