Unwinding Risk Mitigation
IN 2007, with the passage of the Food and Drug Administration (FDA) Amendments Act, the FDA was granted new authority to require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug outweigh its risks. An REMS, which can be required at the time a drug is approved and/or once it has gone to market, has been instituted for a number of drugs. Some REMS requirements are more complicated than others; however, REMS programs have one thing in common: They all affect pharmacists.
A Broad Spectrum
The depth of pharmacist involvement in implementing REMS plans depends on each REMS. Fortunately, the majority of REMS plans are fairly cut-and-dry.
“When you look at the list of drugs for REMS, the most common REMS is a medication guide,” said James M. Hoffman, Pharm.D., M.S., BCPS, medica- tion outcomes and safety officer at St. Jude Children’s Research Hospital in Memphis. That sounds simple enough, but the challenge lies in the language: Medication guides tend to stress toxic- ity and risks.
To help patients understand both the potential positive and negative actions of a drug, St. Jude creates and distributes its own patient education materials to give out along with the FDA-required medication guides.
“Some med guides can concern patients, so we put a lot of effort into our patient education materials to make sure patients receive a balanced message,” Hoffman said.
The requirement to distribute medication guides and patient education materials appears, at first glance, to be fairly straightforward. However, the REMS requirements for some drugs, such as erythropoiesis-stimulating agents (ESAs), are a lot more complicated and can become burdensome, said David Chen, M.B.A., ASHP’s director of Pharmacy Practice Sections.
“The ESA REMS requires a paper system. Pharmacists need to collect agreements from the patients and physicians, verify that the physician has had a conversation with the patient about the drug, and maintain records in case there is an audit,” Chen said. “If a patient shows up without the right paperwork, it can take a while to track down the physician and get him or her to fax it over. This represents time away from other patient care.”
Chen added that such require- ments cast pharmacists into the role of enforcer, a role that is not reimbursed or compensated. “ASHP supports the FDA’s authority and intent, which is safety, but the question is, ‘How do we find the balance?’” he said. “It’s easy to say that it only takes six to 10 minutes to counsel a patient and comply with the REMS, but if a pharmacist has to do that several times a day, it adds up.”
An Uncertain Future
REMS requirements put forth by the FDA are not standardized, and there are more on the way. In June, drug manufacturers proposed a new REMS for long-acting and extended-release opioids, a plan that required prescriber and patient education with an eye toward reining in misuse of the drugs. In late July, an FDA advisory committee voted against the REMS, saying it didn’t go far enough.
Although the FDA scrapped the ideas of prescriber accreditation and patient registration programs, and it will be up to the drug manufacturers to offer the required training, that does not mean that other REMSs for other drugs will not require prescriber certification.
Indeed, the FDA has said that if the current REMS is not effective in curtailing the problems stemming from inappropriate use of long-acting and extended-release opioids, the agency may take further steps.
According to JoAnn Stubbings, R.Ph., MHCA, clinical assistant professor, pharmacy practice, and manager, research and public policy, University of Illinois at Chicago College of Pharmacy, the uncertainty surrounding future REMS plans is precisely why it is necessary to have a system in place to implement them as they are released.
“The company gives you what needs to be done, and they have the forms you need to fill out on paper or online,” said Stubbings, “but you still have to incorporate that into your own health care system.”
Creating an REMS Task Force
The University of Illinois Medical Center takes a two-pronged approach to handling REMS. First, a specialty pharmacy task force consisting of several key clinicians and administrators meets regularly. When there is a new REMS, a pharmacist whose specialty is affected by the plan will give a presentation and discuss what has to be done to meet the requirements.
“I strongly recommend that any medical center with an outpatient pharmacy have a task force like this,” said Stubbings. “Once you start investing in REMS and coping with issues of specialty pharmacy, you can get a handle on the business end of it. It has taken us two years, and we’re still learning.”
Second, the medical center develops policies and procedures for each REMS. The center began doing so when a pharmacist in the pulmonary clinic wrote an REMS management policy that covers how the drug needs to be monitored and includes a checklist for prescribers.
When it comes to REMS plans that require certification, Stubbings feels that all pharmacies that can meet the requirements should be certified. “There should be an ‘any willing pharmacy provision,’” she said. “Right now, if a provider is able, the manufacturer may still choose not to certify. They make arrangements with specialty pharmacies as a business decision. I don’t think academic medical centers and other providers should be cut out of the loop.”
Overall, it is important to remember that REMSs are put into place to protect patient safety, she added. “The intent is good. In some cases, it is possible to lose sight of that, because some REMSs have become such a burden, but we should remember that some drugs would not have been approved without it.”
Hoffman agrees. “Obviously, we are seeing an increased workload and complexity in medication use from REMS, and there is no arguing that the extra work is not compensated,” he said. “But there is no one better than a pharmacist to handle the challenges. We have an opportunity to step up and take ownership.”
ASHP: A Voice for Pharmacists
ASHP has been working with the FDA and providing a voice for pharmacists as REMS federal policy takes shape. Over the past year, ASHP has testified before the FDA and submitted written comments, attended meetings with FDA officials, and provided input for meetings covering REMS for opioids and the challenges associated with the development and implementation of REMSs.
To learn more about ASHP’s efforts to advocate for pharmacists regarding REMSs, click here.