Pharmacy Certification:

Instructions:

Designate an Authorized Representative to complete training and to commit to training all staff who will be involved in dispensing ZILBRYSQ.
Review the Healthcare Provider Safety Brochure.
Submit this completed Pharmacy Enrollment Form to the ZILBRYSQ REMS.

Authorized Representative Information:

First Name *

Last Name *

Title / Position *

Pharmacist Nurse Other (please specify)

Authorized Representative National Provider Identifier (NPI) *

Email *

Preferred Method of Communication *

Email Phone

Pharmacy Information:

Pharmacy Name *

Address Line 1 *

Address Line 2

City *

State *

Zip Code *

Phone Number *

Fax Number *

Pharmacy National Provider Identifier (NPI) *

Authorized Representative Attestations

As the Authorized Representative, I must:

Review the Healthcare Provider Safety Brochure.
Train all relevant staff who will be involved in dispensing ZILBRYSQ using the Healthcare Provider Safety Brochure.
Establish processes and procedures to verify the prescriber is certified and document the findings.
Establish processes and procedures to contact the prescriber to assess the patient’s vaccination status for up to date meningococcal vaccines (MenACWY and MenB) according to the current Advisory Committee on Immunization Practices (ACIP) recommendations including antibacterial drug prophylaxis if needed before treatment initiation and document the findings.
For patients who are not up to date with meningococcal vaccines when starting treatment: Establish processes and procedures to assess the patient’s vaccination status for up to date meningococcal vaccines including antibacterial drug prophylaxis if needed by contacting the prescriber before dispensing prescriptions up to 6 months after the first dose and document the findings.

Before dispensing the first dose, all pharmacy staff must:

Verify the prescriber is certified and document the findings through the processes and procedures established as a requirement of the REMS.
Assess the patient’s vaccination status for up to date meningococcal vaccines (MenACWY and MenB) including antibacterial drug prophylaxis if needed by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS.

For up to 6 months after dispensing the first dose, all pharmacy staff must:

Verify the prescriber is certified and document the findings through the processes and procedures established as a requirement of the REMS.
For patients who are not initially up to date with meningococcal vaccines when starting treatment: Assess the patient’s vaccination status for up to date meningococcal vaccines (MenACWY and MenB) including antibacterial drug prophylaxis if needed by contacting the prescriber and document the findings through the processes and procedures established as a requirement of the REMS.

After the first 6 months of dispensing, all pharmacy staff must:

Verify the prescriber is certified and document the findings through the processes and procedures established as a requirement of the REMS.

At all times, my pharmacy must:

Report adverse events suggestive of meningococcal infection to UCB, Inc. by email at ds.usa@ucb.com.
Not distribute, transfer, loan, or sell ZILBRYSQ, except to certified pharmacies.
Maintain records of staff’s completion of REMS training.
Maintain records that all processes and procedures are in place and are being followed.
Comply with audits carried out by UCB, Inc. or a third party acting on behalf of UCB, Inc. to ensure that all processes and procedures are in place and are being followed.

To maintain certification to dispense, any new Authorized Representative must:

Enroll in the REMS by completing and submitting this Pharmacy Enrollment Form to the REMS.

I acknowledge that I have read the above information and agree to comply with the conditions listed when dispensing ZILBRYSQ.