Understanding Spravato® Strict Delivery Requirements

Strict Handling and Distribution Controls

Spravato^® is classified as a Schedule III controlled substance, requiring stringent oversight:

• Restricted distribution available only through certified healthcare facilities enrolled in the REMS program
• Patients must also be enrolled in the REMS program prior to receiving treatment
• Both the pharmacy and the provider facilities must complete training and certification to prescribe, dispense, and administer Spravato^®
• Secure storage of Spravato^® is a must to prevent unauthorized access or misuse and abuse

Supervised Administration and Patient Monitoring

Patients cannot self-administer Spravato^® at home. Instead, it must be given under medical supervision in a certified healthcare setting:

• In-clinic administration under the direct observation by a healthcare provider as the patient self-administers the nasal spray
• Post-dose monitoring due to potential side effects (sedation, dissociation, blood pressure increases), patients must remain in the clinic for at least 2 hours post-administration
• Transportation precautions are necessary for the patient to not drive or operate machinery until the day after receiving Spravato^®

Required Documentation for Proof of Delivery for PBM Audits

Ensure you have proper documentation of dispensing to a certified healthcare setting. You must have the following documentation:

• Name, address and telephone number of the providers office
• Printed name, title, signature and date of the representative receiving the order
• Patient name, dose, number of devices dispensed and the date of the dispensing

See our November 2019 Newsline article, Spravato^® – Watch the Billing!, for proper billing information, including package size and billing units.

PAAS Tips:

• Review REMS program requirements for Spravato^®
• Make sure the patient address, physician address, and physician DEA# are on the front of the prescription order