Another of the providers’ key concerns is the extra red-tape burdens imposed by the REMS, which, they say, have the potential to dampen the prescribing of clozapine – the exact opposite of its intended effect.
By mandating that only registered prescribers can write for clozapine, the REMS can cause problems for hospitals. “If a patient comes in for a medical reason and happens to be on clozapine, it’s impossible for us to get our internal medicine physicians registered just so they can prescribe it for their one patient who comes through,” Dr. Maroney said. Her workaround has been to make sure all the hospital’s psychiatrists are registered and that patients on clozapine have a psych consult, regardless of the reason they’re hospitalized. This, she acknowledged, could drive up costs.
Dr. Megan Maroney
“Here at my hospital, I tend to work out the issues for my prescribers so that they can start patients and continue them, and I think we’ve been doing a pretty good job. But I wonder about places without the manpower to do that or that don’t have a psych pharmacist who can work with them,” she said.
The REMS “is a major obstacle, and it’s more complicated now than it was before,” said Dr. Lindenmayer, who also is affiliated with the Manhattan Psychiatric Center in New York, an institution that manages about 100 patients on clozapine. “The excessive registry demands, and sending doctors letters about all the potential terrible side effects, will discourage providers. Clozapine is already difficult to prescribe: You have to have a pharmacy lined up, you have to have a lab lined up, you have to have a patient that gets the prescription and the blood test in a timely manner, and you are not being reimbursed at any higher rate by having a clozapine patient.”
Dr. Glick agreed. “Clozapine is one of our best drugs, but the most difficult to manage – as it takes a lot of time and effort. This is one more step making it more complicated.”
Dr. Maroney said that at her institution, she’s already seen a chilling effect from the REMS. Recently, she said, “my prescribers and I were going over all the changes and some of them said, ‘Just forget it, I’ll put [patients] on something else.’ And I said, ‘No – the whole point of a lot of the changes was to make [clozapine] more accessible.’ ”
Dr. Lindenmayer said he considers the REMS – or at least the extra layers of bureaucracy and certification it imposes – to have been a misguided move by the FDA. “I am not aware that there have been more deaths recently due to clozapine prescribing, and haven’t seen any upsurge of morbidity and mortality in the literature, which I follow closely.” Relatively few prescribers use clozapine, he said, and those who do “are fairly careful and knowledgeable about what they’re doing. So they’re preaching to the choir,” he said.
Yet Dr. Maroney said she remains optimistic that the REMS and the providers will be able to reach common ground – eventually: “The College of Psychiatric and Neurologic Pharmacists has been communicating with the FDA to hammer out these issues. I think it should get better. I just don’t know when that will occur and how many of these issues will be completely addressed.”
The FDA spokesperson confirmed that the agency was seeking provider input to improve the Clozapine REMS, and that several changes already had been made in response to provider concerns.