REMS Programs Lead to Added Responsibilities for Nurse Practitioners

TON - February 2010 Vol 3, No 1 — June 10, 2010

The US Food and Drug Administration (FDA) has identified six opioid products that will require Risk Evaluation and Mitigation Strategies (REMS). Advanced practice nurses (APNs) who want to continue prescribing opioids will need to follow several new practices, according to an educational presentation by Marilyn Haas, PhD, RN, CNS, ANP-BC, nurse practitioner for palliative and supportive care at Care Partners in Asheville, North Carolina.

"REMS are strategies to manage a potential or known serious risk of a drug or biological product," explained Haas during her presentation. "In other words, REMS will help all parties understand the side effects and reduce prescription problems. The overall goal is to improve patient safety."

She reported that on February 6, 2009, the FDA sent letters requiring that pharmaceutical companies manufacturing certain opioids develop REMS programs, including medication guides, communication plans (such as special brochures to prescribers and educational materials to patients), and an implementation system for healthcare practitioners.

The FDA's focus was on opioids containing fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone and includes more than 60 products. Prescribing APNs will be required to obtain training certifications by enrolling in the pharmaceutical companies' REMS.

In addition, APNs will be responsible for creating a new system, incorporating order sets, protocols, and evaluation procedures "to ensure drugs are dispensed only to patients with evidence of safe use."

APNs must work with the nursing staff on setting up protocols for educating patients on how they're going to be receiving their medications, how to take them, and that they must enroll in patient-registry programs. "The new process is really going to be a collaborative effort between the nurse practitioner, the nurse, and the patients," said Haas.

Physicians and pharmacists will also be required to take training and certification. "Right now, the programs just use specialty pharmacies, which can be a really positive thing as only one pharmacy will know about the patient and what medications he or she is taking. So there will be more control over potential abuse of the drug and some good safeguards.

"Of course there are also barriers to using specialty pharmacies," admitted Haas. "It takes some time to get that medicine processed and then to the patient. It's not like they can just go out and get it filled everywhere."

Many of the products now have a medication guide, communication plan, elements to assure safe use, and an implementation plan; others have medication guides only. "So it's really important that APNs educate themselves on the specifics of each product's REMS requirements, including listening to webinars," Haas said.

She advised that the first step for APNs should be to register online as prescribers as soon as possible to avoid any delays in getting medications to their patients. "Ultimately, you don't want to deny patients that medication just because you are not a prescriber that has gone through the process. I'd also advise asking for support from nurse navigators to help enroll patients in the registries."

She cautioned that numerous surveys from the pharmaceutical companies will also need to be filled out documenting safe use, per FDA requirements.

"The educational process is actually pretty easy. It just takes time out of your busy schedule to get approval to prescribe the needed medication. But if you do it now, then you won't get caught with having to do a whole bunch of REMS programs at once," concluded Haas.

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