CLZ02 Clozapine REMS Data Entry Naming Convention Guide v11.0
True or False- Agents are supposed to use spaces when creating naming conventions.
A) True
B) False
Answer:
B) False.
ANC values must be entered into the REMS program in which of the following?
A) per percentage
B) per gram
C) per unit milliliter
D) per unit microliter
Answer:
D) Per unit microliter
How is severe neutropenia defined?
A) Severe neutropenia is defined as ANC less than 500/μL
B) Severe neutropenia is defined as ANC more than 500/μL
C) Severe neutropenia is defined as ANC ranging from 1000/μL - 1500/μL
D) Severe neutropenia is defined as ANC ranging from 4500/μL - 5500/μL
The correct answer:
A) Severe neutropenia is defined as ANC less than 500/μL.
Answer can be found on page 5 of Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
When experiencing technical issues while managing inbound fax documents for the Clozapine REMS program, you should resolve the issue by doing which of the following?
A) Ask your TL or manager to report the issue
B) Submit a support ticket
C) Contact Tech Support
D) Close the page and try again later
Answer:
C) Contact Tech Support
Answer can be found on page 3 of Clozapine REMS Fax Processing- User Guide.
Which of the following is not a stakeholder?
A) Prescribers
B) Prescriber Designees
C) Authorized Representatives
D) Insurance Coordinators
Answer:
D) Insurance Coordinators
What is the correct abbreviation for “Outpatient Pharmacy Enrollment Form”?
A.) ORxEF
B.) OpEF
C.)OPRxEF
D.) There is no abbreviation used for this form
Answer:
A.) ORxEF
True of false.
When a patient is missing their PSF, their status will appear as ‘Missing PSF’ under treatment status located under the PR’s patient list
A) True
B) False
Answer:
A) True.
Fill in the blank. Choose the answer that best completes the following statement-
“A REMS is a strategy to manage known or potential risks associated with a drug or group of drugs and is required by the _______ for clozapine to ensure that the benefits of the drug outweigh the risk of severe neutropenia”
FBI
FDA
CDC
TDR
Answer:
The correct answer is 2) FDA (Food and Drug Administration). Answer can be found on page 3 of Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
Which of the following is the purpose of the Agent Console?
A) It is used to track changes associated with each specific field. It tracks the user who made the change, when the change was made and the old and new values
B) It is used to classify and process the unique document that was received. Represents the final documentation for uploading to an external system
C) It is used by and designed for REMS Clozapine users to find, update, and create fax records quickly by displaying records and related items as tabs on one screen
Answer:
The correct answer is C) It is used by and designed for REMS Clozapine users to find, update, and create fax records quickly by displaying records and related items as tabs on one screen.
Answer can be found on page 5 of Clozapine REMS Fax Processing- User Guide.
True or false.
Does a distributor have to enroll in the Clozapine REMS?
A) True
B) Flase
Answer: Yes.
Yes, clozapine is only available through the Clozapine REMS. As part of a restricted distribution REMS program, distributors will need to enroll in the new Clozapine REMS in order to be able to continue purchasing and distributing clozapine.
What document type is defined as- “Due to facsimile or email transmission issues, there is no identifiable information on the document and cannot be tied to a stakeholder profile.”
A) Legible
B) Illegible
C) Accepted
D) Rejected
Answer:
B) Illegible
If a Prescriber’s status in admin is "Unknown", this means all of the following EXCEPT?-
A) Has created login credentials
B) May have completed the PR KA
C) Has completed a PR Enrollment form
Answer:
C) Has completed login credentials
**when status is "Unknown" it means the PR has NOT completed a PR EF**
Displayed in system as Unknown; Meaning- Has created login credentials, may have completed the Prescriber Knowledge Assessment but has not completed a Prescriber Enrollment Form
True or False- REMS is an acronym that stands for Risk Evaluation Mitigation Strategy
Answer: True.
Answer can be found on page 3 of Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
True or False- Agents can assign Received Documents to themselves as well as other Clozapine REMS users
A) True
B) False
Answer:
A) True.
Answer can be found on page 22 of Clozapine REMS Fax Processing- User Guide.
True or False-
Changes to a stakeholders user name will require a support ticket.
A) False
B) True
Answer:
B) True.
The correct example of a complete Pharmacy Knowledge Assessment would look like/follow the format of which of the following?
A) JaneSmith_PtEF_12Aug2022_Complete
B) JaneSmith_PtEF_01Oct2022_Verbal
C) 1962834135_KARx_27Jul2022_Complete
D) JaneSmith_ANCLRF_18Dec2022_Complete
Answer:
C)1962834135_KARx_27Jul2022_Complete
A PR calls asking if the CC received their faxed PR Enrollment Form. Where can this document be found in REMS Admin?
A) Manage Stakeholder – Prescriber
B) View REMS Materials
C) Stakeholder PDF MGMT
D) Task List
Answer:
C) Stakeholder PDF MGMT
Which of the following is not true about Benign Ethnic Neutropenia (BEN)?
A) BEN is a condition observed in certain ethnic groups whose average ANCs are lower than “standard” laboratory ranges for neutrophils
B) Patients with BEN are not at increased risk for developing clozapine-induced neutropenia
C) Patients who have been diagnosed with BEN do not have a separate ANC monitoring algorithm when treated with clozapine
Answer:
C) Patients who have been diagnosed with BEN do not have a separate ANC monitoring algorithm when treated with clozapine
*Patients diagnosed with BEN do in fact have a separate ANCE monitoring algorithm when treated with CLZ as opposed to patients who are not diagnosed with BEN
Which of the following can an agent NOT do on the Transform Document page?
A) Zoom in/out on the document
B) Add a signature
C) View a smaller version of the document image
D) Expand the document and select the page(s) you want to transform
Answer:
B) Add a signature.
*This is not a feature within the Transform Document page.
Answer can be found on page 27 of Clozapine REMS Fax Processing- User Guide.
True or False-
Is there an ANC calculator available for stakeholders to utilize?
Answer: True.
The ANC calculator can be found on the clozapinerems.com website once the user logs in.
If a stakeholder profile cannot be created due to stakeholder information being illegible or incomplete, what is the proper naming convention abbreviation used to replace the incomplete (NPI, first / last name, or WD name)?
A) "?"
B) "N/A"
C) There is no abbreviation, whatever is illegible or incomplete it is left blank.
D) "UNK"
Answer:
D) "UNK".
If a stakeholder profile cannot be created due to the stakeholder information being illegible or incomplete, NPI, first / last name, or WD name) is removed from the naming convention and replaced with ‘UNK’. For example, an incomplete Prescriber Enrollment Form will be named: UNK_PEF_27Febl2022_Incomplete”
True or false. The Transitional Dispense Rationale (TDR) will continue to be used after FDA suspension has ended.
Answer- False.
“This functionality (TDR) will only be used until the FDA suspension is ended.”
Which of the following is an ANC level within “Normal Range”?
A) 1000 - 1499/μL
B) ≥ 1500/μL
C) 500- 999/μL
D) <500//μL
Answer:
B) ≥ 1500/μL.
The answer can be found on page 7 of Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
Can users unsubscribe to a Report?
A) Yes, users can edit the subscription or unsubscribe at any time
B) No, a user can edit the subscription but cannot unsubscribe
C) No, users must submit a support ticket to unsubscribe to a report
Answer:
A) Yes, users can edit the subscription or unsubscribe at any time.
Answer can be found on page 49 of Clozapine REMS Fax Processing- User Guide
Where can a prescriber find a list of pharmacies that are certified in the Clozapine REMS?
Answer: A prescriber can obtain a list of participating pharmacies by selecting the "Find" dropdown on the Home page of the Clozapine REMS website.