REMS AUDITING
Risk Evaluation and Mitigation Strategies (REMS) programs include regulatory requirements imposed by the (FDA) to manage known or potential serious risks associated with certain prescription drugs. These programs are designed to ensure that patients can still receive the benefit of these medications despite associated risks, particularly when the risks are significant and can't be adequately addressed through routine prescribing and dispensing safeguards.
IPS develops protocols for each audit and works collaboratively to ensure protocol design meets the need of each unique REMS program. IPS currently audits pharmacies, wholesalers, and health care settings to ensure compliance with REMS requirements.
Pharmacy Audits: Pharmacy audits assess compliance with specific requirements that pharmacies must follow to dispense REMS products. These audits include, but are not limited to, assessment of the following compliance areas:
Evaluation of process and procedures for training all relevant staff involved in dispensing REMS product.
Confirmation that designation of Authorized Representative staff is accurate and current.
Review of policies and procedures for compliance with REMS requirements to ensure appropriate dispensing of REMS product with all requisite authorizations.
Wholesaler Audits: Wholesaler audits assess compliance with specific requirements that wholesalers must follow to distribute REMS products. These audits include, but are not limited to, assessment of the following compliance areas:
Verification of annual registration of the wholesaler.
Verification that only FDA-approved REMS products are being distributed by the wholesaler.
Verification of shipping REMS product only to wholesalers registered that are registered and activated within the REMS program.
Corrective and Preventive Actions (CAPAs): IPS compiles the results of each audit on a regular basis and provides results back to the REMS program and plan sponsors. For auditees with Minor Findings, IPS assists the auditee to correct the relevant issues and come back to compliance with the program. IPS will also create, process, and monitor a CAPA for any auditee that requires a CAPA due to Major or Critical Findings. Each CAPA is unique to the auditee and is closely monitored. Once the CAPA is complete IPS will communicate with the REMS Program to notify them of compliance status.