Please review these training and summary documents below. After review, please complete this competency exam. https://forms.office.com/r/6xMqVCHq5b

Bookmark these sites and docs for future reference and use.
https://www.ultsolrems.com/ 🔖

DOC 1️⃣- UCI's REMS PROGRAM SUMMARY      
UltSol REMS Program Summary v2.pdf   https://healthuci.sharepoint.com/:b:/s/GRP-InfusionPharmacy2/ETnPttH85hRKh6r92YMOXQsBqecgcsuy_xNJ9-Z24Lbqrw 

DOC 2️⃣- REMS HEALTHCARE SETTING & PHARMACY (HCS) TRAINING SLIDES      
https://media.pharkeep.com/view?m=AtuN5ychx

DOC 3️⃣- PATIENT VACCINE GUIDE   
https://media.pharkeep.com/view?m=zCj7mVlxQ

DOC 4️⃣- HEALTH PROVIDER SAFETY BROCHURE   
https://media.pharkeep.com/view?m=Lr7Qp1OFq

SOP for Accessing and Documenting Meningococcal Vaccination Status

1. Purpose

To establish pharmacy procedures for assessing and documenting meningococcal vaccine status and antibacterial prophylaxis for patients prescribed ULTOMIRIS or SOLIRIS per the ULTOMIRIS and SOLIRIS REMS requirements.

2. Scope

Applies to all pharmacists and support staff involved in dispensing ULTOMIRIS or SOLIRIS at this pharmacy.

3. Responsibilities

  • The Authorized Representative is responsible for certification, training, oversight, and audit readiness.
  • Pharmacists must review REMS guidance and confirm vaccination status prior to each dispense.

4. Definitions

  • REMS: Risk Evaluation and Mitigation Strategy
  • RDA: REMS Dispense Authorization
  • ACIP: Advisory Committee on Immunization Practices
  • MenACWY: Meningococcal vaccine for serogroups A, C, W, Y
  • MenB: Meningococcal vaccine for serogroup B

5. Procedure

A. Initial Steps Before First Dispense

  1. Verify prescriber REMS certification on REMS portal.
  2. Assess patient’s vaccination status for MenACWY and MenB vaccines per ACIP guidelines:
    • MenACWY: 2 doses at least 8 weeks apart, booster every 5 years
    • MenB (Bexsero): 2 doses 1 month apart, booster every 2–3 years
    • MenB (Trumenba): 3 doses (0, 1–2, and 6 months); if dose 2 is ≥6 months after dose 1, dose 3 may be skipped
  3. If the patient is not up to date, confirm:
    • Vaccines will be administered ASAP
    • Antibacterial prophylaxis is prescribed and initiated
  4. Document vaccination and prophylaxis status in REMS Portal before generating RDA.

B. Subsequent Dispenses (up to 6 Months from First Dose)

  1. Review prior documentation and reassess vaccination status.
  2. Ensure booster or missing doses have been received if not previously complete.
  3. Document findings in the REMS Portal for each dispense.

C. Dispenses After 6 Months

  1. Continue obtaining RDA authorization by verifying prescriber certification.
  2. Additional vaccination documentation not required unless requested during audit.

D. Emergency Situations

  • If treatment is urgent and vaccination not complete:
    • Dispense is allowed only if antibacterial prophylaxis is initiated and RDA is obtained under emergency settings.

6. Record Keeping

  • Maintain records of:
    • REMS training for all relevant staff
    • Vaccination and prophylaxis documentation
    • RDA confirmations per dispense
  • Records must be audit-ready within 180 days post-certification.

🗂 Checklist: ULTOMIRIS/SOLIRIS REMS Pharmacy Compliance

Use this checklist at each dispensing stage:

✅StepNotes
☐Confirm Prescriber REMS CertificationUse REMS Portal
☐Verify patient’s MenACWY vaccine statusDates and type
☐Verify patient’s MenB vaccine statusBexsero or Trumenba
☐If not vaccinated, confirm antibacterial prophylaxis initiatedRecord drug, duration
☐Document all findings in REMS PortalBefore dispensing
☐Generate and record RDA authorizationPer REMS Portal
☐Print and include Patient Safety Card if not previously providedCarry during treatment
☐Log event in internal tracking systemInclude pharmacist initials
☐Maintain documentation for audit180-day timeline