Healthcare REMS Program SOP

Healthcare REMS Program SOP

Document Identification

Program Name:

SOP Number:    Effective Date:

Prepared By:    Approved By:

Purpose

This Standard Operating Procedure (SOP) establishes the responsibilities, processes and documentation requirements for administration of the Risk Evaluation and Mitigation Strategy (REMS) Program associated with the specified therapeutic product(s). It defines enrollment, verification, dispensing, monitoring, adverse event reporting and record retention requirements to ensure patient safety and regulatory compliance.

Scope

This SOP applies to all staff, prescribers, and pharmacies participating in the REMS Program under this organization, including outpatient dispensing, inpatient administration, and any contracted specialty pharmacies. It covers processes from patient enrollment through program exit or drug discontinuation.

Definitions

REMS: Risk Evaluation and Mitigation Strategy. Enrollment: the documented process by which a patient is registered into the REMS Program and determined eligible to receive the product. Verification: confirmation of required training, counseling, or certification prior to dispensing. Adverse Event: any untoward medical occurrence temporally associated with use of the drug.

Responsibilities

The Program Manager is responsible for overall REMS compliance, oversight of enrollment logs, training records and audit coordination. Prescribers are responsible for completing required prescriber education and confirming patient counseling. Pharmacists are responsible for verifying eligibility, documenting dispensing, and ensuring patient counseling and informed consent are completed prior to each initial dispense.

Key Contacts:

Procedure — Patient Enrollment and Eligibility

Enrollment must be completed before initial dispensing unless specified otherwise in program-specific guidance. The enrolling prescriber must confirm the patient understands risks and monitoring requirements and must document informed consent in the medical record.

Procedure — Verification and Documentation

The following items must be verified and documented prior to initial dispense. Maintain documentation in the designated REMS record system. Check each applicable item and record identifier or date where required.

Prescriber completed required REMS training and certification
Patient received counseling and provided informed consent
Pharmacy enrolled and authorized to dispense under REMS
Required laboratory or monitoring results documented (if applicable)

Procedure — Dispensing and Counseling

Pharmacists must follow the dispensing checklist for each initial fill and any refill that requires re-verification. Counseling must include risks, safe use, required monitoring, and emergency procedures. Provide written patient materials where required and document that materials were provided.

Dispense Authorization:

Authorized for initial dispense    If authorized by exception, document rationale:

Adverse Event Reporting and Escalation

All suspected adverse events, medication errors or safety complaints potentially related to the REMS product must be documented in the medical record and reported to the REMS Program Manager within 24 hours of awareness. Serious events require immediate escalation to clinical leadership and regulatory reporting per organizational policy.

Compliance Monitoring and Audits

Periodic audits will be conducted to verify adherence to enrollment, verification, counseling and documentation requirements. Audit findings must be documented, and corrective actions must include root cause analysis, remediation, and follow-up verification.

Training and Competency

All personnel with responsibilities under this SOP must complete initial REMS training prior to performing duties and complete annual refresher training. Completion must be recorded in personnel training files.

I attest that I have completed the required REMS training and understand my responsibilities to follow the procedures herein.

Privacy and Confidentiality

All patient information collected and maintained under this SOP is subject to applicable privacy and confidentiality obligations. Access to REMS records is limited to authorized personnel and disclosures are permitted only as required for patient care, program administration, or as required by law.

Staff acknowledgement: I understand and will comply with privacy and confidentiality obligations.

Records Retention and Confidential Storage

All REMS records, including enrollment logs, counseling notes, adverse event reports and audit records, shall be retained for a minimum period specified below unless otherwise required by regulation or organizational policy.

Program Change Control and Deviations

Any deviation from this SOP or changes to REMS processes must be documented, investigated, and authorized by the Program Manager. Corrective and preventive actions shall be implemented and recorded.

Approval and Review

This SOP shall be reviewed at intervals specified below or sooner if program requirements change. Reviews shall confirm that procedures remain adequate and that roles and responsibilities are current.

Attachments and Forms

Attach or reference the following program-specific items as applicable: patient enrollment form, prescriber certification form, pharmacy enrollment form, counseling script, adverse event report template and audit checklist.

Certification

By signing below, the undersigned certifies that they have read and understand the procedures contained in this REMS Program SOP and that they have authority to implement and enforce the practices described herein within their respective areas of responsibility. The undersigned also certify that records and documentation required by this SOP will be maintained in accordance with the retention and confidentiality provisions set forth above.

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