- Clinic name
- Supervising psychiatrist name
- Name of prescribers interested in becoming registered through REMS
- Name of registered nurses (RNs) or psychiatric technicians who will be trained for administration and monitoring of ZYPREXA RELPREVV
Upon receiving approval from DMH Pharmacy for the DO clinic to be established as a ZYPREXA RELPREVV REMS certified site, the clinic supervising psychiatrist must ensure the following are completed and understood by all staff who will be involved in prescribing, administering, or monitoring ZYPREXA RELPREVV: - DO Clinics
- Complete the Healthcare Facility Registration Form every three (3) years and submit it via one of the following:
- Fax to 1-877-772-9391
- Electronically to the ZYPREXA RELPREVV Patient Care Program.
- Email DMH Pharmacy with documentation once registration is approved.
- Identify a pharmacy that is enrolled in the ZYPREXA RELPREVV Patient Care Program and can deliver the injection kit to the clinic.
- At no time should the injection kit be delivered or dispensed from the pharmacy to the client.
- Identify an area in the clinic suitable for the client to be continuously monitored for three (3) hours post-injection for post-injection delirium/sedation syndrome (PDSS).
- Identify RN(s) or psychiatric technician(s) who can monitor the client for at least three (3) hours.
- Prescriber
- Complete the Prescriber Registration Form every three (3) years and submit via one of the following:
- Fax to 1-877-772-9391
- Electronically to ZYPREXA RELPREVV Patient Care Program
- Email DMH Pharmacy with documentation once registration is approved.
- Complete the ZYPREXA RELPREVV Required Prescriber Training and ensure the following:
- Ability to identify the clinical presentation of PDSS
- Understanding of how to manage suspected cases of PDSS until emergency response personnel are available
- Prior to initiating treatment, ensure the client is:
- Stable and tolerating oral olanzapine at doses between 10-20 mg
- Informed about the risks versus benefits of the therapy, including the potential for PDSS
- Informed that they cannot drive or operate heavy machinery for the remainder of the day
- Provided with a copy of the ZYPREXA RELPREVV Medication Guide
- Enrolled in the ZYPREXA RELPREVV Patient Care Program and provided with a completed copy
- Ensure orders are written to the correct certified pharmacy in OrderConnect.
- Complete (or designate appropriate staff to complete) and submit the Patient Monitoring Safety Form within 7 days of every injection administration.
- Upload the Patient Monitoring Safety Form to the client’s record
- Ensure that a report is submitted to the ZYPREXA RELPREVV Patient Care Program within 24 hours of any suspected PDSS case.
- RN
- Complete the Required Healthcare Facility Staff Training and ensure the following:
- Ability to identify the clinical presentation of PDSS
- Understanding of how to manage suspected cases of PDSS until emergency response personnel are available
- Complete the Reconstitution and Administration training video and poster.
- Provide the medication guide to the client prior to each injection.
- Ensure the client is actively enrolled in the ZYPREXA RELPREVV Patient Care Program prior to each injection.
- Ensure ZYPREXA RELPREVV order is active in OrderConnect prior to injection.
- Ensure the client has a designated driver post-injection.
- Reconstitute and administer medication.
- Patient Registration
- Client enrollment includes a signed Patient Registration Form by the client or caregiver to ensure understanding of the following:
- ZYPREXA RELPREVV Patient Care Program data collection requirements
- Risks and benefits of therapy
- Client shall sign the attestation/registration.
- Attestation/registration shall be scanned and uploaded into the client’s record
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