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 RMH 916.3002 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 RMH 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 RMH Health Build/Pharmacist Workflow in Place

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 RMH Health build/HCP Workflow and Pharmacist Informational Notes

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

• Sites enrolled: REH, RGS, RMH, RMP, RSC, RSH
• REMS site:  Alvimopan REMS
• JIT background: information brochure
• RMH required RLM/E+: Pharm.Alvimopan.REMS Training
  • Alvimopan REMS 1, Alvimopan REMS 2, Alvimopan REMS 3,
    
    
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