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The goal of the Sodium Oxybate REMS is to mitigate the risks of serious adverse outcomes resulting from
inappropriate prescribing, misuse, abuse, and diversion of sodium oxybate by:
Informing prescribers, pharmacists, and patients of:
The risk of significant central nervous system (CNS) and respiratory depression associated with
sodium oxybate
The contraindication of use of sodium oxybate with sedative hypnotics and alcohol
The potential for abuse, misuse, and overdose associated with sodium oxybate
The safe use, handling, and storage of sodium oxybate
Ensuring that pharmacy controls exist prior to filling prescriptions for sodium oxybate that:
Screen for concomitant use of sedative hypnotics and other potentially interacting agents
Monitor for inappropriate prescribing, misuse, abuse, and diversion of sodium oxybate
Notify prescribers when patients are receiving concomitant contraindicated medications or there
are signs of potential abuse, misuse, or diversion
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers).
Healthcare providers who prescribe sodium oxybate must:
To become certified to
prescribe
Review the drug’s Prescribing Information.
Review the following: Prescriber Brochure.
Enroll in the REMS by completing the Prescriber Enrollment Form
and submitting it to the REMS.
Before treatment
initiation (first dose)
Assess the patient’s health status to determine if sodium oxybate is
medically appropriate by screening for history of alcohol or
substance abuse, sleep-related breathing disorders, compromised
respiratory function, and depression or suicidality. Document and
submit to a certified pharmacy using the Prescription Form.
Assess the patient’s health status to determine if sodium oxybate is
medically appropriate by screening for concomitant use of sedative
hypnotics, other CNS depressants, or other potentially interacting
agents. Document and submit to a certified pharmacy using the
Prescription Form.
Counsel the patient on the serious risks and safe use, handling,
and storage of sodium oxybate using the Patient Quick Start Guide.
Enroll the patient by completing and submitting the Patient
Enrollment Form to the REMS.
Order the prescription using the Prescription Form and submit it to
Before treatment
re-initiation
For patients disenrolled for suspicion of abuse, misuse, or
diversion: communicate with the pharmacy regarding all relevant
patient history and re-enroll the patient if the prescriber and
pharmacist agree.
For patients with a lapse in treatment of 6 months or longer: order
the prescription using the Prescription Form and submit it to a
certified pharmacy.
During treatment;
within the first 3
months of starting
treatment and
recommended every 3
months thereafter
Assess the patient for: concomitant use of sedative hypnotics,
other CNS depressants, or potentially interacting agents; serious
adverse events; and signs of abuse and misuse including an
increase in dose or frequency of dosing, reports of lost, stolen, or
spilled medication, and drug-seeking behavior.
At all times
Report all potential serious adverse events, including CNS
depression, respiratory depression, loss of consciousness, coma,
and death; and any cases of suspected abuse, misuse, or diversion
to the REMS.
Assess the patient’s potential for abuse, misuse, and diversion.
Document and submit all instances of behavior that give rise to a
reasonable suspicion of abuse, misuse, or diversion, including all
requests for early refills, and all reports of lost, stolen, destroyed,
or spilled drug using the Risk Management Report.
Report requests to disenroll a patient for suspected abuse, misuse,
or diversion to the REMS using the Risk Management Report.
Patients who are prescribed sodium oxybate:
Before treatment
initiation
Review the Patient Quick Start Guide.
Receive counseling from the prescriber on the serious risks
associated with sodium oxybate and safe use, handling, and
storage of sodium oxybate using the Patient Quick Start Guide.
Enroll in the REMS by completing the Patient Enrollment Form with
the prescriber. Enrollment information will be provided to the
REMS.
Complete the Patient Counseling Checklist with the pharmacist.
During treatment
Adhere to the safe use conditions described in the Patient Quick
Start Guide.
Complete the Patient Counseling Checklist with the pharmacist
based on changes in your medication and/or medical history.
During treatment;
within the first 3
months of starting
treatment and
recommended every 3
months thereafter
Be monitored by your prescriber for concomitant use of sedative
hypnotics, other CNS depressants, or potentially interacting
agents; serious adverse events; signs of abuse and misuse
including an increase in dose or frequency of dosing; reports of
lost, stolen, or spilled medication; and drug-seeking behavior.
Before treatment reinitiation,
after lapse in
treatment for 6 months
or longer
Complete the Patient Counseling Checklist with the pharmacist.
At all times
Inform your prescriber and the pharmacy about any new
medications you may be taking or medical conditions you may
have.
Pharmacies that dispense sodium oxybate must:
To become
certified to
dispense
Designate an Authorized Representative to carry out the certification
process and oversee implementation and compliance with the REMS on
behalf of the pharmacy.
Have the Authorized Representative review Certified Pharmacy Training
Module A and Certified Pharmacy Training Module B.
Have the Authorized Representative successfully complete the Module A
Knowledge Assessment and Module B Knowledge Assessment and submit
both to the REMS.
Have the Authorized Representative enroll in the REMS by completing and
submitting the Pharmacy Enrollment Form.
Train all relevant staff involved in dispensing using the Certified Pharmacy
Training Module A.
Have all relevant staff involved in dispensing, successfully complete the
Module A Knowledge Assessment and submit it to the REMS.
Train all pharmacists involved in dispensing using the Certified Pharmacy
Training Module A and Certified Pharmacy Training Module B.
Have all pharmacists involved in dispensing: successfully complete the
Module A Knowledge Assessment and Module B Knowledge Assessment and
submit both to the REMS.
Establish processes and procedures to assess the patient’s concomitant use
of sedative hypnotics, other CNS depressants, or other potentially
interacting agents that are either unknown to the prescriber or pose a high
risk of serious interaction.
Establish processes and procedures to verify the following: the patient and
prescriber are enrolled, the patient has no other active sodium oxybate
prescriptions
Establish processes and procedures to verify and document the following
by contacting all other REMS for oxybate products: the patient has no
other active prescriptions that overlap with the current prescription for
sodium oxybate by obtaining oxybate prescription information of last
dispense date, days’ supply, and prescriber’s name; and the patient and
prescriber have not been disenrolled from any of the REMS for oxybate
products for suspected abuse, misuse, or diversion.
Establish processes and procedures to verify all prescription information
including patient name and two additional identifiers, prescriber name and
information, dose, titration information (if applicable), number of refills,
dosing directions, total quantity (days’ supply), and concomitant
medications.
Establish processes and procedures to assess the patient’s potential for
abuse, misuse, and diversion by reviewing the alerts and Risk Management
Report histories in the REMS.
Establish processes and procedures to provide 24-7 toll-free access to a
Sodium Oxybate REMS trained pharmacist; to dispense no more than a
one-month supply for the initial shipment and no more than a three-month
supply for subsequent shipments; and to ship, track, and verify receipt of
sodium oxybate to the patient or patient-authorized adult designee using
an overnight service.
Establish processes and procedures to report each prescription filled for
sodium oxybate to all other REMS for oxybate products and document to
the REMS.
Establish processes and procedures to reconcile sodium oxybate inventory
using the pharmacy’s inventory management system.
Establish processes and procedures to provide dispensing data and
shipment and receipt dates to the REMS.
Before
dispensing
For new patients and existing patients who restart sodium oxybate
treatment after not receiving product for 6 months or longer: Counsel the
patient using the Patient Counseling Checklist. Document and submit to the
REMS.
For patients who report a change in their medication use or medical
history: Document the change and submit to the REMS using the Patient
Counseling Checklist.
Assess the patient’s concomitant use of sedative hypnotics, other CNS
depressants, or potentially interacting agents that either are unknown to
the prescriber or pose a high risk of serious interaction through the
processes and procedures established as a requirement of the REMS.
Verify in this REMS that the patient has no other active sodium oxybate
prescriptions that overlap with the current prescription for sodium oxybate
through the processes and procedures established as a requirement of the
REMS. Document and submit to the REMS.
Verify the following by contacting all other REMS for oxybate products
through the processes and procedures established as a requirement of the
REMS: the patient has no other active prescriptions for oxybate products
that overlap with the current prescription for sodium oxybate by obtaining
oxybate prescription information of last dispense date, days’ supply, and
prescriber’s name; and the patient and prescriber have not been
disenrolled from any other REMS for oxybate products for suspected abuse,
misuse, or diversion. Document and submit to the REMS.
Assess the patient’s and their prescriber’s potential for abuse, misuse, and
diversion by reviewing the alerts and Risk Management Report history in
the REMS. Document the confirmation to the REMS.
Obtain authorization by contacting the REMS to verify the pharmacy is
certified, the prescriber is certified, the patient is enrolled, the Patient
Counseling Checklist is completed as required, the alerts and Risk
Management Report history for the patient and their prescriber are
reviewed by the pharmacist and the patient has no active, overlapping
prescriptions for oxybate products.
For patients previously disenrolled for suspicion of abuse, misuse or
diversion: communicate all relevant patient history to the prescriber and
determine whether to re-enroll the patient if the prescriber and pharmacist
agree.
Verify the patient’s prescription information, including patient name and
two additional identifiers, prescriber name and information, dose, titration
information (if applicable), number of refills, dosing directions, total
quantity (days’ supply), and concomitant medications through the
processes and procedures established as a requirement of the REMS.
For patients who request an early refill or if abuse, misuse, or diversion is
suspected: Discuss the request or concern with the prescriber.
Dispense no more than a one-month (30-day) supply for the initial
shipment.
Dispense no more than a three-month (90-day) supply for subsequent
shipments.
After dispensing,
within 1
business day
Report each prescription filled for sodium oxybate to all REMS for oxybate
products through the processes and procedures established as a
requirement of the REMS. Document and submit to the REMS.
Before shipping
Verify the patient’s shipping address and that the patient or patientauthorized
adult designee will be available to receive the shipment through
the processes and procedures established as a requirement of the REMS.
Ship sodium oxybate directly to each patient or a patient-authorized adult
designee through the processes and procedures established as a
requirement of the REMS.
Provide the patient with the Patient Quick Start Guide with the first
shipment.
After shipping
Track and verify receipt of each shipment of sodium oxybate through the
processes and procedures established as a requirement of the REMS.
Document and submit the dispensing data, and shipment and receipt dates
to the REMS.
To maintain
certification to
dispense
Have a new Authorized Representative review Certified Pharmacy Training
Module A and Certified Pharmacy Training Module B.
Have a new Authorized Representative successfully complete the Module A
Knowledge Assessment and Module B Knowledge Assessment and submit
both to the REMS.
Have a new Authorized Representatives enroll in the REMS by completing
the Pharmacy Enrollment Form and submitting it to the REMS.
To maintain
certification to
dispense, every
year
Train all relevant staff involved in dispensing sodium oxybate using the
Certified Pharmacy Training Module A.
Have all relevant staff involved in dispensing sodium oxybate, successfully
complete the Module A Knowledge Assessment and submit it to the REMS.
Train all pharmacists involved in dispensing sodium oxybate using the
Certified Pharmacy Training Module A and Certified Pharmacy Training
Module B.
Have all pharmacists involved in dispensing successfully complete the
Module A Knowledge Assessment, and the Module B Knowledge
Assessment and submit both knowledge assessments to the REMS.
At all times
Provide 24-7 toll-free access to a Sodium Oxybate REMS trained
pharmacist.
Ship sodium oxybate directly to the patient or a patient-authorized adult
designee using an overnight service.
Document and report all potential adverse events reported by all sources
including any CNS depression, respiratory depression, loss of
consciousness, coma, and death to the REMS.
Report lost, stolen, destroyed, or spilled drug to the REMS using the Risk
Management Report.
Monitor for all instances of patient and prescriber behavior that give rise to
a reasonable suspicion of abuse, misuse, and diversion, including all
requests for early refills, and all reports of lost, stolen, destroyed, or spilled
drug. Report to the REMS using the Risk Management Report.
Report requests to disenroll a patient for suspected abuse, misuse, or
diversion to the REMS using the Risk Management Report.
Not distribute, transfer, loan, or sell sodium oxybate.
Not stock sodium oxybate in retail pharmacies.
Maintain records of staff training and completion of knowledge
assessments.
Maintain records of inventory reconciliation using the pharmacy’s inventory
management system.
Maintain records of all processes and procedures including compliance with
those processes and procedures.
Comply with audits carried out by the Sodium Oxybate Applicants or a third
party acting on behalf of the Sodium Oxybate Applicants to ensure that all
processes and procedures are in place and are being followed.
Wholesalers-Distributors that distribute sodium oxybate must:
To be able to
distribute
Establish processes and procedures to ensure that the drug is distributed
only to certified pharmacies.
Train all relevant staff involved in distributing sodium oxybate on the REMS
requirements.
At all times
Distribute only to certified pharmacies.
Maintain records of all drug distributions.
Comply with audits carried out by the Sodium Oxybate Applicants or a third
party acting on behalf of the Sodium Oxybate Applicants to ensure that all
processes and procedures are in place and are being followed.
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
01/17/2024
Revised to make editorial changes.
12/08/2023
Modified to remove the Medication Guide as an element of the REMS, reflect a change in vendor, remove the use of electronic telecommunication to query multiple stakeholder databases, alignment of the Patient Quick Start Guide with the Instructions For Use of labeling, as well as other changes to all REMS materials to allow the REMS to be operational.
Also, all REMS materials were modified to reflect the following additions to the REMS requirements:
Prescribers are required to assess the patient’s potential for abuse, misuse, and diversion and to document and submit all instances of behavior that give rise to a reasonable suspicion of abuse, misuse, or diversion
Pharmacies are required to verify the following by contacting all other REMS for oxybate products through the processes and procedures established as a requirement of the REMS: the patient has no other active prescriptions for oxybate products that overlap with the current prescription for sodium oxybate and the patient and prescriber have not been disenrolled from any other REMS for oxybate products for suspected abuse, misuse, or diversion
Pharmacies are required to report each prescription filled for sodium oxybate to all REMS for oxybate products
Applicants are required to report patient and prescriber disenrollment in the Sodium Oxybate REMS due to suspected abuse, misuse, or diversion to all other REMS for oxybate products by phone
Applicants are required to maintain a process to provide certain sodium oxybate prescription information to verify that the named patient has no other active, overlapping prescriptions for oxybate products and that the patient and prescriber have not been disenrolled from the Sodium Oxybate REMS for suspected abuse, misuse, or diversion
01/17/2017
Approval of the REMS.
Disclaimer: This webpage provides general information about REMS programs
to various REMS participants (e.g., patients, pharmacies, and healthcare providers).
The summary information provided herein is not comprehensive and may not include
all of the information relevant to REMS participants. This webpage does not
constitute a replacement, modification, or revision of the approved REMS document,
including any appended REMS materials. Refer to the approved REMS document
for complete information on the REMS requirements for each approved application.
