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Risk Evaluation and Mitigation Strategies (REMS) Medications and Requirements Chart

The FDA uses Risk Evaluation and Mitigation Strategies (REMS) to ensure high-risk medications are used safely. Because each program is uniquely tailored to a drug's specific risks, the requirements for prescribing, verifying, and dispensing vary between medications. These charts are designed to help navigate the individual protocols and ensure compliance at every step during the inpatient dispensing process.   Use this information in combination with LH 900.3002 REMS Drugs.  Contact your site authorized representative (director, clinical or operations manager) with additional questions regarding dispensing at your site.   The FDA list of REMS drugs is always under review – our list of REMS drugs is updated frequently with additions, deletions and program changes.   See also REMS Public Dashboard, designed to accompany the REMS@FDA site.

Chart Legend:

  • Columns with an “✔︎” under the designated roles indicate requirements for that role related to the REMS programs
  • For medications that are on LH Formulary (including with restrictions), the medication name is linked further in the document to more detailed REMS requirements pertaining to healthcare facilities/pharmacies, prescribers, and/or patients

NOTE: In some instances, a patient may be on a REMS medication and go to a hospital that is not REMS certified. Specific requirements to continue patients on their REMS medications can be seen in the prescribing information and additional information is found at the link below. A pertinent excerpt from that link is also copied below: Roles of Different Participants in REMS | FDA

EXCERPT: “Even if your hospital/health care setting isn’t certified to dispense a REMS drug, a patient who is on a REMS medication may be admitted to your hospital or to your emergency department. For example, if you work in an emergency department, you may be treating a patient who experienced a serious adverse event related to a drug he or she is already taking that has REMS requirements. Patients on a REMS drug may also be admitted to your hospital for an unrelated reason and may need to continue treatment on their REMS drug. If you work in an inpatient setting, it may be important for you to understand that your hospital may not stock certain REMS medications. The approved prescribing information is a good resource for medication information as well as information about specific requirements to continue that patient on a REMS medication. Approved prescribing information can be found at Drugs@FDA: FDA-Approved Drugs or DailyMed. Information about REMS requirements can be found at Approved Risk Evaluation and Mitigation Strategies (REMS), in product labeling, or on REMS-specific websites.

Chart 1.  REMS Medications with Legacy Health Build/Pharmacist Workflow in Place

Medication

Generic (Brand)

Sites Enrolled

RDA/ Portal Access*

POM OK

Certification/Enrollment Requirements (ETASU)*

Pharmacist information/ education

Legacy required SLM/E+

Pharmacy

Prescriber

Patient

Alvimopan

(Entereg®)

LEH, LGS, LMH, LMP, LSC, LSH

 

 

✔︎

 

 

Information brochure

Pharm.Alvimopan REMs Training - SLM, updated 2/21

Bosentan

LMH

 

yes

✔︎

✔︎

✔︎

Pharmacy guide

Pharmacy.In-Patient Bosentan Risk Evaluation and Mitagation Strategy (REMS) - SLM, updated 2/25

Buprenorphine ER
(Brixadi®)

LEH, Unity

 

 

✔︎

 

 

REMS document

 

Buprenorphine ER inj (Sublocade®)

 

✔︎

 

✔︎

 

 

REMS document

 

Collagenase clostridium histolyticum (Xiaflex®)

 

 

 

✔︎

✔︎

✔︎

HCP training guide

 

Eculizumab

(Soliris®)

LEH/RCH, LGS, LMP, LSC, LCI

✔︎

 

✔︎

✔︎

✔︎

HCP safety brochure

 

Eculizumab-aagh

(Epysqli®)

LEH/RCH, LGS, LSC

✔︎

 

✔︎

✔︎

✔︎

HCP safety brochure

 

Esketamine

(Spravato®)

 

 

 

✔︎

 

✔︎

Program overview

Pharm.Esketamine (Spravato) REMS - SLM, 12/21

Etonogestrel implant

(Nexplanon®)

 

 

 

✔︎

✔︎

 

Pharmacy guide

 

Fenfluramine oral solution

(Fintepla®)

LSC

 

yes

✔︎

✔︎

✔︎

Pharmacy guide

 

Iptacopan

(Fabhalta®)

LSC

✔︎

yes

✔︎

✔︎

✔︎

Safety guide

 

Isotretinoin

RCH, Unity

 

yes

✔︎

✔︎

✔︎

Pharmacist guide

LH.Pharmacy.iPLEDGE REMS Training for Isotretinoin Dispensing-SLM, updated 5/23

Lenalidomide

(Revlimid®)

LEH, LGS, LSC, LMH

 

yes

✔︎

✔︎

✔︎

Pharmacy guide

 

Mavacamten

(Campzyos®)

Unity, LSC

 

yes

✔︎

✔︎

✔︎

Program overview

 

Natalizumab

(Tysabri®)

LSC/LCI

 

 

Infusion site

✔︎

Pt Med Guide

Overview

 

Olanzapine

(Zyprexa Relprevv®)

 

 

 

✔︎

✔︎

✔︎

Program Instructions

 

Phentermine-topiramate ER (Qsymia®)

LSC

 

yes

✔︎

 

✔︎

Program Instructions

 

Pomalidomide

LEH, LSC

 

yes

✔︎

✔︎

✔︎

Pharmacy guide

 

Quizartinib

(Vanflyta®)

RCH

 

yes

✔︎

✔︎

✔︎

Prescriber training program

 

Ravulizumab-cwvz (Ultomiris®)

LEH/RCH, LGS, LMP, LSC, LCI

✔︎

 

✔︎

✔︎

✔︎

HCP safety brochure

 

Riociguat

(Adempas®)

LGS, LMP, LSC

 

yes

✔︎

✔︎

✔︎

Prescriber & pharmacy guide

 

Thalidomide

LSC

 

yes

✔︎

✔︎

✔︎

Pharmacy guide

 

Tolvaptan

(Jynarque®)

 

 

yes

✔︎

✔︎

✔︎

Program overview

 

Vigabatrin

(Sabril®, Vigafyde®)

RCH

✔︎

yes

✔︎

✔︎

✔︎

REMS document

PHARM.Vigabatrin REMS Pharmacy Training - SLM, updated 1/26

Definitions:

  • Risk evaluation and mitigation strategy (REMS): a drug safety program that the food and drug administration (FDA) requires for certain medications with serious safety concerns
  • REMS dispense authorization (RDA): A number generated through REMS portal to verify that all safe use conditions have been met before dispensing certain medications
  • Elements to assure safe use (ETASU): REMS requirements that must be performed before the medication can be prescribed, dispensed or received. Additional examples can be found

 

Chart 2.  REMS Medications with Legacy Health build/HCP Workflow and Pharmacist Informational Notes

Medication

REMS program

REMS site*

Formulary

Certification/Enrollment Requirements (ETASU)*

REMS Purpose/Notes to Pharmacists

Pharmacy

Prescriber

Patient


Opioid Analgesic (OA) REMS

✔︎

Yes

✔︎

✔︎

✔︎
  • HCP (providers/pharmacists/nurses) are educated on recommended pain management practices, including counseling patients and appropriate OA prescribing
  • Patients are educated on the risks of OAs and the need for proper storage and disposal of OAs

Buprenorphine Transmucosal Products for Opioid Dependence (BTOD)

✔︎

Yes

✔︎

✔︎

✔︎
  • Mitigate risk of accidental overdose, misuse and abuse
  • Inform prescribers, pharmacists and patients of serious risks associated with BTODs

Denosumab (Prolia)

✔︎

NF OP Use*

 

✔︎

 
  • Mitigate the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD) including dialysis-dependent patients
  • Inform HCPs on the risk of severe hypocalcemia with advanced CKD, est GFR < 30 mL/min
  • Assess for presence of CKD-mineral bone disorder before initiating therapy in patients with CKD

Denosumab-bbdz (Jubbonti)

✔︎

NF OP Use*

 

✔︎

 

Denosumab-bmwo (Stoboclo)

✔︎

NF OP Use*

 

✔︎

 

Denosumab-bnht (Conexxence)

✔︎

NF OP Use*

 

✔︎

 

Denosumab-desu (Osvyrti)

✔︎

NF OP Use*

 

✔︎

 

Denosumab-dssb (Ospomyv)

✔︎

NF OP Use*

 

✔︎

 

Denosumab-kyqq (Bosaya)

✔︎

NF OP Use*

 

✔︎

 

Denosumab-qbde (Enoby)

✔︎

NF OP Use*

 

✔︎

 

Develisib (Copiktra)

✔︎

No

 

✔︎

 
  • Mitigate the risks of fatal and/or serious toxicities, including treatment-related mortality, infections, diarrhea or colitis, cutaneous reactions and pneumonitis

Melphalan (Hepzato)

✔︎

Kit - No

 

✔︎

 
  • Mitigate the risks of severe peri-procedural complications including hemorrhage, hepatocellular injury and thromboembolic events.  REMS applies to Hepzato Kit ONLY.

Mycophenolate

✔︎

Yes

 

✔︎

 
  • Mitigate the risk of embro-fetal toxicity associated with use during pregnancy

Teduglutide [rDNA origin] (Gattex)

✔︎

No

 

✔︎

 
  •  Mitigate the risks of possible acceleration of neoplastic growth and enhancement of gastric, small intestinal and colon polyp growth, gastrointestinal obstruction and biliary and pancreatic disorders associated with medication use.

Definitions

  • REMS site – product or program REMS site
  • NF OP Use – medication is Inpatient Non-formulary and Restricted to Outpatient Use. Follow optimal setting workflow.

Alvimopan

Alvimopan is Formulary, Restricted to patients undergoing small or large bowel resection, or radical cystectomy with urinary diversion only.  The goal of the Alvimopan REMS is to mitigate the potential risk of myocardial infarction by ensuring alvimopan is used only short-term, and includes health care setting and wholesaler-distributor requirements for dispensing.

Receipt of an INPATIENT order

  • Dosing is limited to no more than 15 doses per patient for administration in the hospital inpatient setting only.
    • If patient was recently discharged, may complete 15-dose course with hospital supply (order from RPh Pref List).
  • Orders should be placed by orderset whenever possible. See Colorectal Surgery ERAS Preop, Colorectal Surgery Post-Op.
  • When ordering from the RPh Pref List – confirm patient age > 18, indication, contraindications and recent opioid use (required). Select frequency AND number of doses (default)/hours/days.  Review notes to pharmacy for contraindications: complete bowel obstruction, severe hepatic dysfunction, ESRD, use of therapeutic doses of opioids for 7 consecutive days prior to admission or chronic opioid use. If use is contraindicated, do not verify order. Call provider to clarify whether use is appropriate for this patient.
  • POM: no.  Alvimopan is a formulary agent, must dispense hospital supplied medication to complete 15-dose course on admission.

Drug procurement

  • McKesson drop ship item: 2 business days. Teva – first order, 2 business days to set up prior to shipping, will require state license.

Additional resources

Bosentan

Bosentan is a formulary agent, although not routinely stocked by sites due to the REMS program.  The goal of the Bosentan REMS is to mitigate the risk of hepatotoxicity, and includes provider, pharmacy, patient and wholesaler-distributor requirements for dispensing.

 Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • To order bosentan, inpatient pharmacies must be certified to dispense through designating an authorized representative (AR). Once drug is received, the pharmacist must verify the patient is enrolled in the REMS program, or will be enrolled in the program prior to discharge under the care of a certified prescriber. 
    • Dispense no more than a 15 days’ supply at discharge.

Drug procurement

  • McKesson drop ship item: 2 business days. Teva – first order, 2 business days to set up prior to shipping, will require state license.

Additional resources


Buprenorphine ER (Brixadi®)

This buprenorphine dosage form (extended release subcutaneous) is Formulary Restricted to Outpatient Use, with exception for PES (UBH), ESUDS (UBH) and as a pilot program for LEMC inpatient use.  The goal of the Brixadi REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration, and includes health care setting, pharmacy and wholesaler-distributor requirements for dispensing.

Receipt of an INPATIENT order

  1. The ordering provider must acknowledge understanding of the REMS requirements by answering “yes” to the order question when placing the order.
  2. The pharmacist will review the order for completeness and appropriateness for indication, dose, and drug interactions.
    • For Unity PES/ESUD, dispense weekly formulation only from pharmacy inventory.
    • For Unity patients continued as inpatient, transition to sublingual buprenorphine during inpatient days.
    • For LEMC Pilot Program, change the dispense code to “Pt Supplied Med” in the verification queue to prevent charge generation. Limited strengths of weekly and monthly formulations are available, please check inventory prior to dispensing.

At all times for INPATIENT dispensing

  • Not for self-administration. Do not dispense directly to patient.
  • Do not distribute, transfer, loan, or sell Brixadi to other healthcare settings or pharmacies without manager approval.  

Drug procurement

  • Order via Authorized Distributor (CurascriptSD). NOTE: Shipment of product may take up to 5 to 7 business days from time of ordering.
  • To set up initial order, call or email rep. Hospital REMS ID and DEA of site required.

Additional resources

Buprenorphine ER (Sublocade®)

This buprenorphine dosage form (extended release subcutaneous, Sublocade) is Restricted to Outpatient Use, with dispensing by Legacy Apothecaries for clinic administration.  Sublocade is inpatient non-formulary.   The goal of the Sublocade REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration, and includes health care setting, pharmacy and wholesaler-distributor requirements for dispensing.

Receipt of an INPATIENT order

  • Do not fill. Buprenorphine extended-release injection (Sublocade) is for clinic administration only.

Drug procurement

  • Order through CurascriptSD. To set up initial order, call or email rep.  Hospital REMS ID and DEA of site required.

Additional resources

Collagenase Clostridium Histolyticum (Xiaflex)

The goal of the Xiaflex REMS program is to mitigate the risks of corporal rupture (penial fracture) and other serious penile injuries associated with the use of Xiaflex for Peyronie’s disease, and includes health care providers, patients, pharmacy and wholesaler-distributor requirements for dispensing.

Drug procurement

  • McKesson drop ship item: 1 business day, cutoff 1:30p. Endo – first order, 800-462-3636; 2 business days to set up prior to shipping.

Additional resources

Eculizumab (Soliris®) and Eculizumab-aagh (Epysqli®)

This medication is Inpatient Non-formulary and Restricted to Outpatient Use. Inpatient use requires approval by a physician department leader (i.e. Medical Director or Chair, or hospital CMO) collaborating with a pharmacy leader.
See Non-Formulary, Restricted to Outpatient Medication process.  The goal of the Ultomiris and Soliris, and the Epysqli REMS programs are to mitigate the risk of serious meningococcal infections, and includes health care provider, patient, health care setting/pharmacy and wholesaler-distributor requirements for dispensing.

Receipt of an INPATIENT or OUTPATIENT (Day Treatment Unit or Infusion Center) order

  1. Verify Provider Enrollment by accessing the associated REMS page:
    Eculizumab (Soliris®): https://ultsolrems.com
    Eculizumab-aagh (Epysqli®): https://www.epysqlirems.com
    • If provider is not enrolled, pharmacist must contact the provider to enroll.  
    • Provider will need to email or fax the Prescriber Enrollment Form available on the REMS site.  
    • Do not proceed until provider enrollment is confirmed. 
    • NOTE: ordering provider and provider name in RDA MUST match. 
  2. Collect patient information: Name, DOB, MRN, indication, dose, ordering physician from EHR and/or REMS portal.
    • Review or enter patient information and vaccination information into REMS portal.
    • Ensure patient has received meningococcal vaccinations for serogroups A, C, W, Y, and B based on vaccination recommendations according to the current Advisory Committee on Immunization Practices (ACIP) recommendations. 
      • If meningococcal vaccinations are not fully up to date, ensure antibacterial drug prophylaxis is initiated before treatment
      • Update vaccination history, as applicable, based on EHR or provider supplied documentation.  
      • Document findings in EHR and portal. 

Vaccinations: Ensure patient has plans to receive vaccines covering all serogroups listed above. These must be ordered and signed by the ordering provider. 

      • Assess vaccination status prior to initiation; patients should receive meningococcal vaccine(s) at least 2 weeks prior to treatment initiation.  
      • In unvaccinated patients, administer meningococcal vaccine(s) as soon as possible and initiate antibacterial prophylaxis.

Prophylaxis: All patients should also receive antibacterial prophylaxis when receiving C5 inhibitors.

Adults:

      • Penicillin VK 500 mg PO twice daily
      • In the case of penicillin allergy, Ciprofloxacin 500 mg daily or Azithromycin 500 mg daily may be used

Pediatrics:

      • Penicillin VK:
      • ≤3 years: Oral: 125 mg twice daily
      • >3-12 years: Oral: 250 mg twice daily
      • > 12 years: Oral 500 mg twice daily

Azithromycin:

      • 5 mg/kg/dose (maximum 500mg) PO daily

3. Generate REMS Dispense Authorization (RDA) for dispensing by accessing the REMS portal.

4. Drug procurement

    • Eculizumab (Soliris): McKesson drop ship, 1 business day, cutoff 1:30p.
    • Eculizumab-aagh (Epysqli): McKesson Plasma & Biologics by 1300, for next day.
    • Evening/weekend emergent shipment: Contact site leadership to determine procurement.

Prior to each dispense for continuation of therapy:  

  1. Review patient vaccination status for meningococcal vaccines including antibacterial drug prophylaxis, if needed, before dispensing prescriptions.  
    • If vaccine status is not up to date or antibacterial drug prophylaxis needed, do not dispense and contact provider.
  2. If vaccination status is up to date and/or prophylaxis is provided with plan to complete vaccination, obtain authorization to dispense each prescription by accessing the REMS portal and generating RDA.   

At all times for either INPATIENT or OUTPATIENT dispensing:  

  • Do not distribute, transfer, loan, or sell eculizumab or eculizumab-aagh, except to other certified healthcare settings or certified pharmacies.  
  • To verify that a receiving facility is certified to receive drug, search the Certified Participant Locater on www.ultsolrems.com or by contacting the REMS Call Center at 1-888-765-4747.  

Additional resources

Esketamine (Spravato)

Esketamine spray is a formulary agent, restricted to Unity and requires insurance approval prior to administration.  The goal of the Spravato REMS is to mitigate the risk of serious outcomes resulting from sedation and dissociation and respiratory depression caused by administration, and includes health care setting, patient, pharmacy and wholesaler-distributor requirements for dispensing.

 Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • To order esketamine, inpatient pharmacies must be certified to dispense through designating an authorized representative (AR). Once drug is received and the healthcare setting is certified, verify the order for the patient. 
    • Do not distribute, transfer, loan or sell Spravato® except to certified dispensers.
    • Do not dispense Spravato® for use outside a certified healthcare setting.

Drug procurement

  • CurascriptSD; to order, call or email rep – hospital REMS ID and DEA of site required.

Additional resources

Etonogestrel implant (Nexplanon)

The goal of the Nexplanon REMS is to mitigate complications due to improper insertion and removal, and includes health care provider, pharmacy and wholesaler-distributor requirements for dispensing.  There is no need for inpatient pharmacies to register or become certified, only specialty pharmacies and the health care providers managing care of the patient.

Drug procurement

  • CurascriptSD; to order, call or email rep – name of onsite MD/NPI required.

Additional resources

Fenfluramine oral solution (Fintepla)

Fenfluramine is a formulary agent (pending May 2026 review), although not routinely stocked by sites due to the REMS program.   The goal of the Fintepla REMS is to mitigate the risk of valvular heart disease and pulmonary arterial hypertension, and includes health care provider, patient, pharmacy and wholesaler-distributor requirements for dispensing.

 Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • To order fenfluramine, inpatient pharmacies must be certified to dispense through designating an authorized representative (AR). Once drug is received, the pharmacist must verify the patient is enrolled in the REMS program, or will be enrolled in the program prior to discharge under the care of a certified prescriber. 
    • Dispense no more than a 15 days’ supply at discharge.

Additional resources

Iptacopan (Fabhalta)

Iptacopan is a formulary agent, although not routinely stocked by sites due to the REMS program.   The goal of the Fabhalta REMS is to mitigate the risk serious infections caused by encapsulated bacteria, and includes health care provider, patient, pharmacy and wholesaler-distributor requirements for dispensing.

Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • To order iptacopan, inpatient pharmacies must be certified to dispense through designating an authorized representative (AR). Once drug is received, the pharmacist must verify the prescriber is certified and the patient’s vaccination status is current to obtain an authorization to dispense.  If dispensing upon discharge, do not dispense more than a 30 days’ supply. 

Additional resources

 

Isotretinoin

Isotretinoin is a formulary agent, although not routinely stocked by sites due to the REMS program.   The goal of the Isotretinoin REMS is to mitigate the risk of embryo-fetal toxicity, and includes health care provider, patient, pharmacy and wholesaler-distributor requirements for dispensing.

 Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • To order isotretinoin, inpatient pharmacies must be certified to dispense through designating an authorized representative (AR). Once drug is received, the pharmacist must verify the prescriber is certified, the patient is enrolled, the counseling is complete, the patient is not pregnant, and dispensing is within the designated timeframe. 

Drug procurement

  • McKesson, local DC following set up with McKesson iPledge program.

Additional resources

Lenalidomide

Lenalidomide is a non-formulary agent.   The goal of the lenalidomide REMS is to mitigate the risk of embryo-fetal toxicity, and includes health care provider, patient and pharmacy requirements for dispensing.

 Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • To order lenalidomide, inpatient pharmacies must be certified to dispense through designating an authorized representative (AR). Once drug is received, the pharmacist must obtain an authorization number to verify the prescriber is certified and the patient is enrolled in the REMS program.

Drug procurement

  • McKesson drop ship item: 2-7 business days depending on manufacturer (multiple available).

Additional resources

Mavacamten (Camzyos)

Mavacamten is a formulary agent (pending May 2026 review), although not routinely stocked by sites due to the REMS program.   The goal of the Camzyos REMS is to mitigate the risk of heart failure due to systolic dysfunction, and includes health care provider, patient, pharmacy and wholesaler-distributor requirements for dispensing.

 Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • To order mavacamten, inpatient pharmacies must be certified to dispense through designating an authorized representative (AR). Once drug is received, the pharmacist must obtain an authorization to dispense to verify the prescriber is certified and the patient is enrolled in the REMS program.

Drug procurement

  • McKesson drop ship, following set-up/approval by McKesson; OR Curascript to order, call or email rep.

Additional resources

Natalizumab (Tysabri)

Natalizumab is Inpatient Non-formulary and Restricted to Outpatient Use.  Inpatient use requires approval by a physician department leader (i.e. Medical Director or Chair, or hospital CMO) collaborating with a pharmacy leader, see  Non-Formulary, Restricted to Outpatient Medication process.   The goal of the Tysabri REMS is to mitigate the risk progressive multifocal leukoencephalophy (PML), and includes health care provider, patient, pharmacy, infusion sites and wholesaler-distributor requirements for dispensing.

 Receipt of a INPATIENT or OUTPATIENT (Day Treatment Unit/Infusion Center) order

  • Verify the infusion site is authorized to dispense; infusion nurse to obtain authorization to dispense each infusion by contacting the REMS program, or confirm receipt of Notice of Patient Authorization.
  • Infusion nurse to provide the patient with Medication Guide and assess patient’s health status, documenting using the Pre-Infusion Patient Checklist.
  • Infusion nurse to submit the Pre-Infusion Checklist to the REMS program regardless if the patient receives the infusion.

Drug procurement

  • McKesson drop ship (ICS/Biogen): 1 business day, cutoff 1:30p

Additional resources

Olanzapine (Zyprexa Relprevv)

This dosage form of olanzapine (extended-release injectable suspension, Zyprexa Relprevv®) has not been requested for formulary status and is not routinely stocked by sites due to the REMS program.   The goal of the Zyprexa Relprevv REMS is to mitigate the risk of negative outcomes associated with post-injection delirium/sedation syndrome (PDSS), and includes health care provider, patient, pharmacy and health care settings requirements for dispensing.

 Receipt of an INPATIENT order

  • POM: no
  • To dispense Zyprexa Relprevv for clinic or inpatient administration by a certified provider, the pharmacy must be certified through designating an authorized representative (AR). Once drug is received, the pharmacist must obtain an authorization to dispense to verify the prescriber is certified and the patient is enrolled in the REMS program.

Drug procurement

  • McKesson drop ship: 1 business day, cutoff 1:30p. H2Pharma – first order 2 business day to set-up prior to shipping.

Additional resources

Phentermine-topiramate extended release (Qsymia)

Phentermine-topiramate extended-release capsules (Qsymia®) have not been requested for formulary status and are not routinely stocked by sites due to the REMS program.   The goal of the Qsymia REMS is to mitigate the risk of embryo-fetal toxicity, and includes pharmacy and wholesaler-distributor requirements for dispensing.

 Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • To order phentermine-topiramate extended-release capsules, inpatient pharmacies must be certified to dispense through designating an authorized representative (AR). Once drug is received, the pharmacist must provide the patient with a medication guide and patient brochure (Risk of Birth Defects with Qsymia) with each dispense.

Additional resources

 

Pomalidomide

Pomalidomide capsules have not been requested for formulary status and are not routinely stocked by sites due to the REMS program.   The goal of the PS-Pomalidomide REMS is to prevent embryo-fetal exposure, and includes health care provider, patient and pharmacy requirements for dispensing.

Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • To order pomalidomide capsules, inpatient pharmacies must be certified to dispense through designating an authorized representative (AR). Once drug is received, the pharmacist must obtain a confirmation to dispense by contacting the REMS program to verify the prescriber is certified, the patient is enrolled and is not pregnant and the authorization number is valid.

Additional resources

 

Quizartinib (Vanflyta)

Quizartinib (Vanflyta®) has not been requested for formulary status and is not routinely stocked by sites due to the REMS program.   The goal of the Vanflyta REMS is to mitigate the serious risk of QT prolongation, Torsades de Pointes and cardiac arrest, and includes health care provider, patient, pharmacy and wholesaler-distributor requirements for dispensing.

 Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • To order quizartinib inpatient pharmacies must be certified to dispense through designating an authorized representative (AR). Once drug is received, the pharmacist must verify the provider is certified prior to dispensing.

Drug procurement

  • McKesson drop ship, following set-up/approval by McKesson

Additional resources

Ravulizumab-cwvz (Ultomiris®)

Ravulizumab-cwvz is Inpatient Non-formulary and Restricted to Outpatient Use. Inpatient use requires approval by a physician department leader (i.e. Medical Director or Chair, or hospital CMO) collaborating with a pharmacy leader – See Non-Formulary, Restricted to Outpatient Medication process.  The goal of the Ultomiris and Soliris REMS is to mitigate the risk of serious meningococcal infections, and includes health care provider, patient and health care setting/pharmacy requirements for dispensing.

Receipt of an INPATIENT or OUTPATIENT (Day Treatment Unit or Infusion Center) order

  1. Verify Provider Enrollment by accessing the associated REMS page:
    Ravulizumab-cwvz (Ultomiris®): https://ultsolrems.com
    • If provider is not enrolled, pharmacist must contact the provider to enroll.  
    • Provider will need to email or fax the Prescriber Enrollment Form available on the REMS site.  
    • Do not proceed until provider enrollment is confirmed.  
    • NOTE: ordering provider and provider name in the RDA MUST match.
  2. Collect patient information:  Name, DOB, MRN, indication, dose, ordering physician from EHR and/or REMS portal.
    • Review or enter patient information and vaccination information into REMS portal.
    • Ensure patient has received meningococcal vaccinations for serogroups A, C, W, Y, and B based on vaccination recommendations according to the current Advisory Committee on Immunization Practices (ACIP) recommendations. 
      • If meningococcal vaccinations are not fully up to date, ensure antibacterial drug prophylaxis is initiated before treatment
      • Update vaccination history, as applicable, based on EHR or provider supplied documentation.  
      • Document findings in EHR and portal. 

Vaccinations: Ensure patient has plans to receive vaccines covering all serogroups listed above. These must be ordered and signed by the ordering provider. 

      • Assess vaccination status prior to initiation; patients should receive meningococcal vaccine(s) at least 2 weeks prior to treatment initiation.  
      • In unvaccinated patients, administer meningococcal vaccine(s) as soon as possible and initiate antibacterial prophylaxis.

Prophylaxis: All patients should also receive antibacterial prophylaxis when receiving C5 inhibitors.
Adults:

      • Penicillin VK 500 mg PO twice daily
      • In the case of penicillin allergy, Ciprofloxacin 500 mg daily or Azithromycin 500 mg daily may be used

Pediatrics:

      • Penicillin VK:
        • ≤3 years: Oral: 125 mg twice daily
        • >3-12 years: Oral: 250 mg twice dail
        • > 12 years: Oral 500 mg twice daily
      • Azithromycin
        • 5 mg/kg/dose (maximum 500mg) PO daily

3. Generate REMS Dispense Authorization (RDA) for dispensing by accessing the REMS portal.

4. Drug procurement

    • McKesson drop ship: 1 business day, cutoff 1:30p.
    • Evening/weekend emergent shipment: Contact site leadership to determine procurement.

Prior to each dispense for continuation of therapy:  

  1. Review patient vaccination status for meningococcal vaccines including antibacterial drug prophylaxis, if needed, before dispensing prescriptions.
    • If vaccine status is not up to date or antibacterial drug prophylaxis needed, do not dispense and contact provider.
  2. If vaccination status is up to date and/or prophylaxis is provided with plan to complete vaccination, obtain authorization to dispense each prescription by accessing the REMS portal and generating RDA.   

At all times for either INPATIENT or OUTPATIENT dispensing:  

  • Do not distribute, transfer, loan, or sell ravulizumab-cwvz, except to other certified healthcare settings or certified pharmacies.    
  • To verify that a receiving facility is certified to receive drug, search the Certified Participant Locater on www.ultsolrems.com or contacting the REMS Call Center at 1-888-765-4747.

Additional resources

Riociguat (Adempas)

Riociguat is formulary, restricted to Patient’s Own Medication or continuation of home medication; the product is not routinely stocked by sites due to the REMS program.   The goal of the Riociguat shared system REMS is to mitigate the risk of embryo-fetal toxicity, and includes health care provider, patient, pharmacy and wholesaler-distributor requirements for dispensing.

 Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • When dispensing hospital supplied product, verify the female patient is under the care of a certified prescriber, her reproductive status and that she is enrolled in the REMS program prior to dispensing.
  • If dispensing at discharge, dispense no more than a 15-days’ supply.
  • Do not distribute, transfer, loan or sell riociguat except to certified pharmacies

Drug procurement

  • CurascriptSD: to order call or email rep, hospital REMS ID and DEA of site required.

Additional resources

Thalidomide

Thalidomide is formulary, although the product is not routinely stocked by sites due to the REMS program.   The goal of the Thalidomide shared system REMS is to mitigate the risk of embryo-fetal toxicity, and includes health care provider, patient, pharmacy and wholesaler-distributor requirements for dispensing.

 Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • When dispensing hospital supplied product, verify that a prescription authorization number and patient risk category are documented with each prescription dispensed.
  • Do not distribute, transfer, loan or sell thalidomide except with the permission of the REMS

Drug procurement

  • McKesson drop ship: 1 business day, cutoff 1:30p. For first order, contact ER Squibb, 888-423-5436, 2 business days to set-up prior to shipping.

Additional resources

Tolvaptan (Jynarque)

Tolvaptan is a formulary restricted drug, with ordering limited to nephrology and cardiology providers.  The Jynarque® brand product is not routinely stocked by sites due to the Tolvaptan for ADPKD REMS program.   The goal of the Tolvaptan for ADPKD shared system REMS is to mitigate the risk of serious and potentially fatal livery injury, and includes health care provider, patient, pharmacy and wholesaler-distributor requirements for dispensing.

  • The Tolvaptan for ADPKD Shared System REMS applies to tolvaptan products indicated for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). This REMS does not apply to tolvaptan products that are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure and syndrome of inappropriate antidiuretic hormone.

 Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • When dispensing hospital supplied product, verify the prescriber is certified and the patient is enrolled in the REMS program.
  • If dispensing at discharge, dispense no more than a 15-days’ supply.
  • Do not distribute, transfer, loan or sell tolvaptan (Jynarque).

Drug procurement

  • McKesson drop ship: 3-5 business days (generic Jynarque only). NOTE: Samsca (+ generic) is not REMS.

Additional resources

Vigabatrin

Vigabatrin is non-formulary and restricted to Patient’s Own Medication or continuation of home medication.  The goal of the Vigabatrin REMS is to mitigate the risk of vision loss associated with therapy, and includes provider, patient, pharmacy and wholesaler-distributor requirements for dispensing.

Receipt of an INPATIENT order

  • POM: yes. If patient supplied medication is available, identify and verify following patient supplied medication workflow (900.3104 Patient’s Own Medications (POM): Inpatient Administration and Use).
  • Inpatient supply provided to patient (patient unable to supply or own supply not sufficient for entirety of hospital stay
    1. Verify Patient Enrollment by accessing the associated REMS page PRIOR to dispensing:  Vigabatrin: https://www.vigabatrinrems.com/
      • If patient is enrolled, obtain authorization code.
      • Document/i-vent: 1) patient REMS ID 2) authorization code within EPIC EHR attached to medication order 3) date of 15-day mark as handoff reminder for 15-day verification
    2.  For continuation of dispensing for 15 days and longer:
        • Confirm and verify that a certified prescriber (affiliated with the healthcare facility or with admitting hospital privileges/prescribing rights – pediatric neurology) authorizes continuing vigabatrin treatment. If provider is not certified in the REMS program, guide provider to register.
        • Pharmacist to verify Patient AND Prescriber Enrollment by accessing the associated REMS page PRIOR to dispensing
        • If patient AND prescriber are enrolled, obtain authorization code.
        • Document/iVent: 1) patient REMS ID, 2) prescriber REMS ID, 3) authorization code within EPIC EHR attached to medication order
    3. Drug procurement
      • McKesson drop ship.  First order needs to be set-up/approved by McKesson, 888-457-4273 or 877-625-2566.
      • Evening/weekend emergent shipment: Contact site leadership to determine procurement.

At all times for INPATIENT dispensing from INPATIENT supply:  

  • Do not dispense more than a 15-day temporary supply of vigabatrin from the inpatient supply to bridge a patient who is discharging from the healthcare facility.
  • Verify the patient is enrolled in the Vigabatrin REMS prior to dispensing vigabatrin by logging into the portal and document the patient’s REMS ID.

Additional resources






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