ENTEREG - Syneos Health

Alvimopan Applicants must provide training materials to healthcare settings that dispense alvimopan.
The training includes the following: Alvimopan REMS Program Kit which includes the Alvimopan REMS Program Overview, Dear Healthcare Provider Letter, Prescriber and Pharmacist Information Brochure and Hospital Pharmacy Enrollment Form. The training materials must be available in hard copy and online.

To support REMS operations, Alvimopan Applicants must:

1. Establish and maintain a REMS website, www.alvimopanREMS.com. The REMS website must include the capability to complete hospital pharmacy certification and the option to print the Prescribing Information and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS website. The REMS website must not link back to the promotional product website(s).
2. Make the REMS website fully operational and all REMS materials available through the website and coordinating/call center.
3. Establish and maintain a REMS coordinating/call center for REMS participants at [1-800 278 0340].
4. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the Alvimopan REMS.
5. Ensure hospital pharmacies are able to enroll in the Alvimopan REMS by fax and online.
6. Provide Alvimopan REMS Kit including an Alvimopan REMS Program Overview, Dear Healthcare Provider Letter, Prescriber and Pharmacist Information Brochure and Hospital Pharmacy Enrollment Form, and the Prescribing Information to REMS participants who (1) attempt to dispense alvimopan and are not yet certified or (2) inquire about how to become certified.
7. Maintain a process to ensure that healthcare settings that want to become certified have a pharmacy in an inpatient hospital that performs bowel resection surgeries.

To ensure REMS participants’ compliance with the REMS, the Alvimopan Applicants must:

1. Verify that the authorized representative’s name and contact information correspond to those of the current designated authorized representative for the hospital pharmacy. If different, the hospital pharmacy must be required to re-certify with a new authorized representative before distribution of alvimopan from the wholesaler/distributer resumes.
2. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: alvimopan distribution and dispensing; certification of hospital pharmacies; and audits of REMS vendors. These records must be readily available for FDA inspections.
3. Establish a plan for addressing noncompliance with REMS requirements.
4. Monitor hospital pharmacies on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, including de-certification.
5. Audit hospital pharmacies, in accordance with the audit plan, no later than 90 calendar days after they become certified, to ensure that all REMS processes and procedures are in place, functioning and support the REMS requirements.
6. Audit all certified wholesalers and distributors within 90 days from the date of their enrollment in the Alvimopan REMS, and annually thereafter to confirm compliance with REMS requirements.
7. Take reasonable steps to improve implementation of and compliance with the requirements in the Alvimopan REMS based on monitoring and evaluation of the Alvimopan REMS.