| Authorized Personnel: Registered nurses, psychiatrists, nurse practitioners, and clinical pharmacists.
Authorized Representative: Personnel assigned to correspond with Janssen Pharmaceuticals and oversee implementation and compliance with the REMS requirements.
Clinic: Any DMH directly operated facility.
Professional Director: A psychiatrist in the directly operated clinic who is registered with the California State Board of Pharmacy as a physician acting in his or her capacity as medical director of the clinic.
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| Prior to each clinic enrolling as a SPRAVATO treatment center, the Professional Director and DMH Pharmacy Chief shall ensure the clinic is in good standing with the California State Board of Pharmacy and the United States Department of Justice.
Esketamine shall only be obtained through a restricted distribution program called SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) as required by the United States Food and Drug Administration (FDA).
The Professional Director shall designate an Authorized Representative in accordance with SPRAVATO REMS Program requirements and provide contact information of the Authorized Representative to the DMH Pharmacy Chief or designee. The Professional Director shall communicate to the DMH Pharmacy Chief or designee any change in the Authorized Representative on the same business day and a new Authorized Representative shall register with the SPRAVATO REMS Program.
Esketamine prescription shall only be sent to a REMS-certified community, retail, or specialty pharmacy.
Under no circumstances shall esketamine be: - Dispensed or given to a client for home use;
- Dispensed to or administered outside of the treatment center under which a client is registered;
- Transferred to another client;
- Loaned to another client;
- Sold to anyone; nor
- Returned to a dispensing pharmacy.
Authorized staff shall follow precautionary steps, monitoring, and documentation requirements detailed in the attached procedure for esketamine administration.
A prescriber shall be onsite during SPRAVATO administration and monitoring.
Authorized Personnel shall notify SPRAVATO REMS in advance if client treatment will be transferred from one REMS-certified Healthcare Setting to another REMS-certified Healthcare Setting.
A permanent record for training shall be kept at the clinic and be readily accessible
A record of all shipments of SPRAVATO received and dispensed shall be kept permanently and be readily accessible. The record shall also include client name, dose, number of devices, and date administered.
The clinic shall comply with audits carried out by Janssen Pharmaceuticals, Inc. or a third-party acting on behalf of Janssen Pharmaceuticals, Inc., to ensure all processes and procedures are in place and being followed.
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