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Our Request: 37-Day Clozapine Prescriptions

In April of 2024, LB was hospitalized in a civil mental health court hospital. After years of struggling with psychosis, LB was finally granted a potentially lifesaving trio: clozapine treatment, one year of court-ordered outpatient treatment, and access to an Athelas® finger prick device for monitoring Absolute Neutrophil Count (ANC).


LB was discharged from the hospital on 300mg of clozapine with weekly ANC testing frequency. His clozapine prescription was written for 30 days – not seven days. The skilled and experienced hospital psychiatrist did the right thing.


When LB got to the pharmacy, the pharmacist dispensed all 30 days of his clozapine prescription. He did not dispense just seven days of pills and tell LB to come back in a week to get another weekly ration of pills. The skilled and experienced pharmacist did the right thing.


The good pharmacist also faced a blocked REMS Dispense Authorization because LB’s monthly Patient Status Form (PSF) hadn’t been signed off – a common situation for patients discharged from a hospital. However, the pharmacist still dispensed the script. He either requested a Dispense Rationale or referred to the FDA’s announcement of “enforcement discretion.” Either way, LB, with support from his family, has been set up for success with clozapine.


But this is NOT happening for most clozapine patients.


The past 35 years have seen various iterations of FDA-mandated programs to ensure clozapine patients adhere to the suggested ANC blood testing schedule (currently weekly for six months, followed by bi-weekly, then monthly after one year – for life). One version of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program involved the trademarked slogan, “No Blood, No Drug.” This extortionist motto represented suffering and death for thousands of US patients unable to participate in frequent, rigorous blood tests but for whom clozapine was likely the only effective treatment for their persistent psychosis or suicidal behavior. This stern mantra was also profoundly insensitive, given the immense risks and torment that accompany abrupt interruptions in clozapine treatment.


In 2021, the FDA made some major changes to the clozapine REMS. The ableist and extortionist logo was abandoned, and streamlined options were given to prescribers to waive missing tests at their discretion. A monthly signing of the PSF was implemented to improve testing flexibility and reduce treatment interruptions.


Previously, pharmacists were required to verify ANC test results depending on the patient’s monitoring frequency. The new 2021 REMS allows patients 37 days to complete the mandatory testing: four tests for weekly, two tests for bi-weekly, or one test for monthly monitored patients. The spacing of tests throughout the month is not defined. Theoretically, a weekly monitored patient could have all four tests completed and entered in the last week of the month and still be eligible to pick up their prescription.


Here’s the problem: The new REMS gives patients 37 days to complete the blood testing requirements but does not expressly authorize patients to receive 37 days of medication.


While the PSF status authorizes a pharmacist to dispense a clozapine prescription, the REMS instructions for the quantity to dispense are as follows:


“The amount of clozapine that can be dispensed depends on when the patient’s next blood draw is scheduled to occur, according to the monitoring frequency requirements. Pharmacies should dispense enough medication to treat the patient with clozapine until the next blood draw/ANC or as directed by the prescriber” (p. 15 of Clozapine and the Risk of Neutropenia: A Guide for Pharmacists)


The Angry Moms have observed significant variation in how these instructions are interpreted. Some, like LB’s pharmacist, are dispensing clozapine quantities exactly as prescribed, giving 30 days of medication even for weekly and bi-weekly monitored patients, consistent with the “as directed by the prescriber” clause. Yet most pharmacists are still rationing pills in weekly and bi-weekly quantities for clozapine patients during their first year of treatment and placing them at high risk of dangerous interruptions.


What good is having 37 days to complete blood testing requirements when patients are not given 37 days of medication?


This is a major flaw in the current clozapine REMS. Any improved flexibility in the blood testing requirements is completely negated by continued limits on dispensed quantities. Most patients and families must still manage a strict blood testing and pharmacy schedule in order to get their medication each week. For some patients, the closest REMS-certified pharmacy is an hour away. Despite the disbanding of the logo, patients continue to face a dangerous and devastating “No Blood, No Drug” policy.


The FDA’s efforts to “fix” the clozapine REMS and ongoing notices of “enforcement discretion” have failed. Clozapine patients and their families continue to face dangerous and deadly treatment interruptions. This problem is widespread and grossly underreported because there is currently no means of monitoring or detecting treatment interruptions.


The clozapine REMS is destroying lives and should be eliminated. As an immediate containment to this public health hazard, The Angry Moms respectfully request that the clozapine REMS expressly authorize every patient to receive 37 days of clozapine regardless of their current testing frequency. This duration reflects a standard monthly script plus at least one week of an emergency supply.


No other lifesaving medications with grave interruption risks are rationed in weekly quantities and with strict limits on emergency doses. Weekly rationing of clozapine is dangerous and discriminatory. This practice must end.


The Angry Moms



92 commentaires


Invité
6 days ago

This is discriminatory and must end

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juliedsammon
04 juin

The horror stories associated with the barriers to receiving clozapine in a timely manner, could be any one of our loved ones with serious mental illness. Where is the professional clinical reasoning behind the regulations? Preventing someone from receiving prescribed treatment is nothing short of homocide. This is a plea to the FDA to provide families/caregivers/patients, with the access needed to manage clozapine in a manner that is in the best interest of the patient. Please allow those with SMI to have an opportunity for consistent wellness, which includes an emergency supply of clozapine......the prescribers have identified the need, so why can't everyone else?

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Invité
31 mai

This is absolutely insane what is happening. This is blunt discrimination against the most vulnerable. Money and power is what drives this corrupt system. We can no longer continue to accept its "sovereign immunity,"when its processes are killing and harming people. Protecting public health is absolutely a fallacy. My daughter with 4 years of recovery is at risk of losing it every month. This month; phlebotomist did not show, she was sick so she did not follow up.The doctor office or pharmacy did not call to alert her. If I had not questioned her on her blood test, it would have been a terrible outcome. We live on edge constantly. 

They can be forced to be accountable, it is time….

FDA settles…

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Invité
27 mai

The amount of stress this system brings on our family is ridiculous and honestly unnecessary. Too many times have we had to wait for the pharmacy to get our LOs numbers before they can even fill the script only to find out they didn’t have enough in stock sending us away empty handed until the next day. We literally get down to one dose which is very stressful because of this ridiculous system. Fix it FDa now.

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Invité
26 mai

Yes! The restrictions are excessive and cause much worry and stress.

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