PAE or Not PAE
"Sally was placed on Clozapine last week and she shared with me that she is now having trouble sleeping." Is this a PAE, if so what is the process?
Yes, this is a PAE because the patient is experiencing trouble sleeping. The process is to warm transfer and provide case number, if cannot warm transfer please complete the PAE intake form.
Pharmacist says, “Sue has taken clozapine forever, so I knew rejection was a system error.”
Yes
Can we enroll patients over the phone?
Yes, Verbal Enrollment process.
How many missed blood draw dates on a PSF can a PR sign for and is there any limits?
All. No limitations.
I am an outpatient facility and I work closely with our inpatient facility. What action needs to be done to move patients from our Inpatient PR to the Outpatient PR?
You can have the Outpatient PR log into their landing page, go to "Manage Patients" and look up the patient. If found, they can simply add. If the patient is not found, then you will need to enroll the patient.
"Penny shared that she is feeling great and stopped taking Clozapine" Is this a PAE, if yes, what are the steps to report?
No, this is not a PAE so does not need to be reported.
Wholesaler calls and says, “We can’t ship our latest purchase of clozapine because we’re locked out of the REMS list of pharmacies.”
-Yes. This indicates that they are either suspended or decertified.
How can ANC values be faxed to the program to be entered for patients
Only on approved program forms; Patient Status Form (PSF) or supplemental ANC LRF (ANC LRF)
How many days of medication can an inpatient pharmacy supply to a patient at discharge?
7 Days
Caregiver states “My child can’t afford their clozapine, so they split the tablets and only takes half the dose they’re supposed to.”
Complete and send PAE form
Pt is not taking the prescribed dose
My patient refused to have their blood drawn. Is this this a PAE?
No, this is non compliance for the patient.
Prescriber calls and states their general population patient decided to stop taking clozapine they is discontinuing them.
-No. The patient can decide to stop taking a medication if they choose. It is only recommended that the prescriber monitor them, not a requirement. (Page 9 of prescriber guide).
How old can Blood Draw Dates be to be successfully entered for a patient?
30 days from Blood Draw Date to time of DE processing
What are the four things prescriber designees cannot do?
If a patient is eligible to reduce their monitoring frequency does the Clozapine REMS need to be notified?
Yes, the monitoring frequency recommendations are described in the Prescribing Information. In the new Clozapine REMS, monitoring frequency is reported to the Clozapine REMS by the prescriber or designee on the monthly Patient Status Form.
"I need to change the dose information for my patient because it is not working for my patient. Can you help?" Is this a PAE and if so, how do you report?
Yes, this is lack of efficacy (failure of expected pharmacologic action). This should be warm transferred and if cannot then the intake form should be completed.
Agent called the pharmacy to inquire on why TDR was issued vs obtaining an RDA. The pharmacy manager said the only AR certified for the pharmacy no longer works there.
Yes,
Complete and send suspected non-compliance form
Staff is issuing RDAs/TDRs without a designated AR and the pharmacy is not authorized to do so without an AR.
Does a KA showing "Successfully Processed" in Stakeholder PDF MGMT mean the KA was passed?
No, the KA will show "Successfully Processed" if it was failed too
Does the VA need to certify and enroll like the rest of the program?
Does the Clozapine REMS need to be advised when a patient is admitted to or discharged from an acute or long-term healthcare setting?
No; the new Clozapine REMS does not track when patients are admitted or discharged. Patient association to a prescriber is updated automatically when a new prescriber enrolls a patient. There is no action required on the part of the previous prescriber.
If a prescriber wishes to remove a patient from their list, they can deactivate the patient via their dashboard.
"I have a patient who shared her Clozapine medication with her friend since her friend was having some of her same symptoms. I wanted to report this to you." Is this a PAE, if so, how do we report?
Yes, because this is an abuse/misuse of Clozapine.
Wholesale Distributor calls to inquire which pharmacies in their area are certified to receive Clozapine medication shipments. W/D was distributing without maintaining record of monthly drug distribution and did not confirm which pharmacies were certified prior to distributing previous shipments.
Yes
Complete and send suspected non-compliance form
W/D not maintaining record of distribution and distributing to non-certified pharmacies.)
In what situations is a PR signature required on a PtEF or PSF?
PtEF and PSF: Only if a patient is being designated as Hospice Care or BEN. PSF only: If it's being marked that a patient missed a blood draw, or requires a Treatment Rationale (ONLY because ANC is <1000/uL for general pop and <500/uL for BEN)
If a pharmacy states they cannot certify because they do not have a NJPI number, what needs to be done?
-Fax the enrollment form indicating they have no NPI and the data entry team will assign a random NPI number.
My patient does not have insurance and require patient assistance. Is there a program available?
CC to transfer caller to manufacturer as Medical Information Request (MIR)