APNA applauds end of Clozapine Risk Evaluation and Mitigation Strategy
In a success for both providers and patients, the FDA has ended the Clozapine Risk Evaluation and Mitigation Strategy (REMS) safety program.
APNA, represented by member Donna Rolin, PhD, APRN, PMHCNS-BC, PMHNP-BC, was part of this recent decision.
The Clozapine Risk Evaluation and Mitigation Strategy was mandated by the Food and Drug Administration (FDA) to manage the risk of severe neutropenia in those treated with clozapine, an antipsychotic usually prescribed to treat schizophrenia.
As of late February, the FDA no longer requires prescribers, pharmacies, and patients to participate in REMS – although the FDA does recommend prescribers continue to monitor patients’ absolute neutrophil count (ANC). The FDA says information on severe neutropenia will remain in the prescribing information for all clozapine medicines.
APNA’s expert representation
“Removal of this barrier will surely increase prescribing of clozapine,” Rolin says. “Providers will continue to monitor safety issues as is done for all psychotropic medications.”
Rolin previously served as Treasurer on the APNA Board of Directors. She is a past recipient of the APNA Board of Directors Student Scholarship.
With her clinical and educational expertise in psychopharmacology, including the use of clozapine and long-acting injectables, Rolin represented APNA in the interdisciplinary group advocating to both the FDA and the CPMG Clozapine Products Manufacturers Group. Other members included the American Psychiatric Association, American Association of Psychiatric Pharmacists, the National Alliance on Mental Illness, and the National Council for Mental Wellbeing.
Rolin shared how an individual living in a rural area was impacted by the REMS program.
“[When she aged out of pediatric psychiatry,] her parents could not find a provider to continue clozapine for her despite numerous, significant hospitalizations in her teens and no other medications being effective,” she says. The parents found Rolin, but the interruption of treatment led to the exacerbation of symptoms and a decline in functioning. “Especially when [the patient] was not doing well, driving an hour to get lab work each month was not ideal and distressing to the patient. She had been on clozapine for about eight years with no side effects or lab abnormalities. The family is thrilled that we may now continue this treatment without excessive trips to the lab.”
About the decision
The group’s November 2024 joint letter to the FDA summarized many of the challenges of the clozapine REMS, including:
- The burden on patients, especially minorities and those living in rural areas
- Potential disruption to the prescribing of the medication, including that one missed dose could cause a patient to have psychosis
- The medication lowered the risk of suicide and tardive dyskinesia
According the letter, data also no longer supports the need for the program: “Numerous studies indicate that there is less risk of agranulocytosis from clozapine than was thought when the drug was approved. Data further indicate that an elevated risk may be time-limited, removing the need for indefinite monitoring.”
At an FDA panel meeting, according to Medscape, agency officials said that 148,000 outpatient clozapine prescriptions were written in 2023. A 2022 article reports about one-third of those with schizophrenia are treatment resistant.
“APNA applauds the FDA’s decision to eliminate the Clozapine Risk Evaluation and Mitigation Strategy requirements,” APNA President Joyce Shea, DNSc, APRN, PMHCNS-BC, FAAN, says. “The elimination of these burdensome requirements will expand access to an important treatment (and in some cases the only one that works) for individuals with schizophrenia.
“APNA is proud to have played a part in this interdisciplinary effort and extends its sincere thanks especially to the families and individuals personally impacted by these requirements who testified and shared their stories.”
Stay up-to-date at CPI
Get all the latest on schizophrenia and treating schizophrenia at the APNA 23rd Annual Clinical Psychopharmacology Institute. It’s June 5-8 in Bethesda, Maryland or on virtual live stream.
Two CPI sessions of note:
Deep Dive into Medications for Schizophrenia, Including Clozapine. Keynote speaker Jonathan M. Meyer, MD, DLFAPA, will examine trends and emerging treatments to provide effective care to this population.
Acetylcholine Neurotransmission, Muscarinic Receptors, and Anticholinergic Burden: Implications for Schizophrenia Spectrum Disorders. With the advent of novel antipsychotic medications modulating acetylcholine, Jeremy Mills, DNP, PMHNP-BC, will give attendees a crucial understanding of muscarinic activity.
>>> You can still save on rates for CPI. Register today!
Published March 2024
About APNA: The American Psychiatric Nurses Association is a national professional membership organization committed to the practice of psychiatric-mental health nursing and wellness promotion, prevention of mental health problems, and the care and treatment of persons with psychiatric disorders. APNA’s membership is inclusive of all psychiatric-mental health registered nurses including associate degree, baccalaureate, advanced practice (comprised of clinical nurse specialists and psychiatric nurse practitioners), and nurse scientists and academicians (PhD). APNA serves as a resource for psychiatric-mental health nurses to engage in networking, education, and the dissemination of evidence. The American Psychiatric Nurses Association is accredited as a provider of continuing nursing professional development by the American Nurses Credentialing Center’s Commission on Accreditation.
