AEPQC & MIR
The name of the J&J Complaint Reporting portal.
What is EZ Reporter?
This individual, designated by a HCS or Pharmacy, oversees REMS compliance and certification.
Who is the Authorized Representative (AR)?
This is the regulatory body responsible for enforcing the controlled substances laws and regulations.
Who is the Drug Enforcement Administration (DEA)?
This is the process of transferring a case to a higher authority for resolution.
What is escalation?
This type of form is used to monitor a patient for sedation, dissociation, or respiratory depression during the required two-hour monitoring period.
What is the Patient Monitoring Form (PMF)?
The abbreviation for an unsolicited inquiry from a healthcare professional, patient, or caregiver seeking scientific or clinical information about Spravato.
What is MIR?
To certify, outpatient healthcare settings must complete this form confirming participation in the REMS program.
What is the Inpatient HCS Enrollment Form?
This is the entity involved in the distribution of a drug that is subject to REMS requirements.
Who is the Distributor?
This is an occurrence when a REMS certified stakeholder or wholesaler-distributor does not comply with or meet a REMS requirements.
What is a non-compliance event?
Before disclosing any Protected Health Information (PHI), CC agents must confirm this federal law’s requirements are met.
What is HIPPA?
Drug exposure during pregnancy and off-label use are examples of this type of event.
What are Special Situations (SS)?
A pharmacy in this status has initiated the certification process but cannot dispense Spravato until all requirements are complete.
What is Incomplete?
This status indicated a KYC form has not been approved by J&J, also seen as the default status following REMS certification.
What is Ok to Distribute - No?
These are specific safety requirements that may be mandated as part of a REMS, such as training, certification, or restricted dispensing.
What are Elements to Assure Safe Use (ETASU)?
Forms may be submitted three ways: fax, phone (with signature later), and this online method.
What is the REMS portal?
The timeframe in which all PQCs must be carefully documented and reported once information is received.
What is one business day?
This person enrolls patients in the REMS program.
Who is the prescriber?
This is who will notifies the REMS of KYC status updates for HCS and pharmacies via email.
Who is J&J?
This status indicated that a stakeholder was previously in "Certified" status and a concern for drug dispensing has been identified.
What is De-certified?
For HCS enrollment, pharmacy enrollment, and Patient Enrollment Forms, signature dates must be within this many calendar days of submission to be valid.
What is 30 days?
This is where we will warm transfer callers reporting a MIR.
What is the J&J Medical Information line?
This status is for patients who have successfully met all REMS program enrollment requirements and is not receiving treatment at the HCS.
What is Inactive?
A reimbursement model where healthcare providers purchase a drug directly and then bill the payer after administering it to the patient.
What is Buy & Bill?
This is a systematic process used to identify, investigate, and resolve issues that arise during product development, manufacturing, or service delivery.
What is Corrective and Preventative Action (CAPA)?
If a form is incomplete, CC agents follow up with up to this many outbound calls, scheduled three business days apart.
What is three calls?