ACTIQ - Examoto, LLC

TIRF Applicants must ensure that healthcare providers, patients, pharmacies, and wholesalers-distributors comply with the following requirements:

TIRF Applicants must provide training to healthcare providers who prescribe TIRF medicines.
The training includes the following educational material: Prescriber Education. The training must be made available on a website and by calling the REMS program.

TIRF Applicants must provide training to pharmacies that dispense TIRF medicines.
The training includes the following educational material: Pharmacy Education. The training must be made available on a website and by calling the REMS program.

To inform healthcare providers about the REMS program and the risks and safe use of TIRF medicines, TIRF Applicants must disseminate REMS communication materials according to the table below:

Target Audience	Communication Materials & Dissemination Plans
Inpatient and outpatient pharmacies that dispense Schedule II drugs and may be involved in dispensing TIRF medicines	REMS Letter: Inpatient Pharmacy Letter with attachment Pharmacy Education; Outpatient Pharmacy Letter with attachment Pharmacy Education. a. Email within 30 calendar days of the approval of the REMS modification and again 1 month later.          a. Send by mail or fax within 45 calendar days of the date the second email was sent if email was undeliverable or unopened. b. Disseminate through the following professional societies and request the letter or content be provided to their members:          b. American Association of Colleges of Pharmacy (AACP), American College of Clinical Pharmacy (ACCP), Accreditation Council for Pharmacy Education (ACPE), Academy of Managed Care Pharmacy (AMCP), American Pharmacists Association (APhA), American Society of Consultant Pharmacists (ASCP), American Society of Health-System Pharmacists (ASHP), Board of Pharmacy Specialties (BPS), Board Certified Oncology Pharmacists (BCOP), National Association of Boards of Pharmacy (NABP), National Community Pharmacists Association (NCPA), National Alliance of State Pharmacy Associations (NASPA)
Inpatient and outpatient pharmacies previously enrolled in the TIRF REMS	REMS Letter: Inpatient Pharmacy Letter with attachment Pharmacy Education; Outpatient Pharmacy Letter with attachment Pharmacy Education 1. Mail or fax within 45 calendar days of approval of the REMS modification (12/23/2020).
Inpatient and outpatient pharmacies, and wholesaler-distributors previously enrolled in the TIRF REMS	REMS Letter: Urgent Notification Regarding TIRF Products Stock Letter Mail or fax within 120 calendar days of approval of the REMS modification (12/23/2020).
Healthcare providers who are likely to prescribe TIRF medicines	REMS Letter: Healthcare Provider Letter with attachment Prescriber Education 1. Email within 30 calendar days of the approval of the REMS modification and again 1 month later.         a. Send by mail or fax within 45 calendar days of the date the second email was sent if email was undeliverable or unopened. 2. Disseminate through the following professional societies and request the letter or content be provided to their members:         a. American Academy of Hospice and Palliative Medicine, American Academy of Pain Management, American Academy of Pain Medicine, American Association of Poison Control Centers, American College of Physicians, American Chronic Pain Association, American Pain Society, American Society of Pain Educators, National Hospice and Palliative Care Organization
Prescribers previously enrolled in the TIRF REMS	REMS Letter: Healthcare Provider Letter with attachment Prescriber Education 1. Mail or fax within 45 calendar days of approval of the REMS modification (12/23/2020).
Healthcare providers	Website Pop-Up Message 1. Publish prominently on the public homepage at www.tirfremsaccess.com on August 28, 2024 and display indefinitely. The Message must appear with each visit to the homepage and require an active click to close it.

To support REMS program operations, TIRF Applicants must:

1. Authorize dispensing for each patient based on receipt of the Patient Status and Opioid Tolerance Form and pharmacy assessment for a change in opioid tolerance. The authorization is valid for one dispensing for up to 30 calendar days from date the prescriber initiates the authorization.
2. Establish and maintain a REMS program website, www.TIRFREMSaccess.com. The REMS program website must include the capability to complete prescriber, pharmacy, and patient enrollment online, document Adverse Events of Special Interest, document opioid tolerance, obtain authorization to dispense, and the option to print the Prescribing Information, Medication Guide, and REMS materials. All product websites for consumers and healthcare providers must include prominent REMS-specific links to the REMS program website. The REMS program website must not link back to the promotional product website(s).
3. Make the REMS program website fully operational and all REMS materials available through the website and coordinating center within 180 calendar days of the REMS modification (12/23/2020).
4. Establish and maintain a REMS program coordinating center for REMS participants at 1-866-822-1483.
5. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the TIRF REMS program. The database must contain information on their enrollment status.
6. Ensure that prescribers and pharmacies are able to complete enrollment by fax and online.
7. Ensure prescribers are able to document opioid tolerance using the Patient Status and Opioid Tolerance Form by fax and online.
8. Ensure prescribers are able to report serious adverse events of accidental exposure, misuse, abuse, addiction, and overdose using the Adverse Events of Special Interest Reporting Form by fax and online.
9. Ensure pharmacies are able to report serious adverse events of accidental exposure, misuse, abuse, addiction, and overdose using the Adverse Events of Special Interest Reporting Form by phone, fax, and online.
10. Ensure pharmacies are able to enroll as an inpatient pharmacy (hospitals, in-hospital hospices, and long-term care facilities that dispense for inpatient use) or as an outpatient pharmacy.
11. Ensure outpatient pharmacies are able to document changes in opioid tolerance by phone and online.
12. Ensure outpatient pharmacies are able to obtain authorization to dispense TIRF medicines by phone and online.
13. Provide Prescriber Enrollment Form, Patient Enrollment Form, Outpatient Pharmacy Enrollment Form, Inpatient Pharmacy Enrollment Form, Prescriber Education, Prescriber Knowledge Assessment, Patient Counseling Guide, Pharmacy Education, Pharmacy Knowledge Assessment, and the Prescribing Information to REMS participants who (1) attempt to prescribe/dispense/distribute TIRFs and are not yet certified or (2) inquire about how to become certified.
14. Notify prescribers and pharmacies within three business days after they become certified in the REMS program.
15. Notify REMS participants 30 calendar days before their enrollment expires and of the need to re-enroll.
16. Provide certified prescribers access to the database of certified pharmacies and enrolled patients.
17. Provide certified outpatient pharmacies access to the database of certified prescribers and enrolled patients.
18. Establish and maintain a registry which includes a reporting and collection system for all outpatients to provide information on serious adverse events including accidental exposure, abuse, misuse, addiction, and overdose.
19. Follow up with the healthcare provider to obtain the reason for discontinuation if the patient is not dispensed a TIRF medicine after 2.5 times the days’ supply of their last prescription’s days’ supply.
20. Ensure that once a report suggestive of accidental exposure, abuse, misuse, addiction, or overdose is received, TIRF Applicants follow up with the healthcare provider to obtain all required data for complete adverse event reporting related to accidental exposure, abuse, misuse, addiction, and overdose under the REMS.
21. Report any overdose that results in a death associated with a TIRF medicine, as soon as possible to FDA but no later than 15 calendar days from the initial receipt of the information by the TIRF Applicants. This requirement does not affect the applicants’ other reporting and follow-up requirements under FDA regulations.

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

1. Ensure a Patient Status and Opioid Tolerance Form is received, and the pharmacy assesses for a change in opioid tolerance for each patient for each dispensing.
2. Verify every two years that the pharmacy’s authorized representative’s name and information correspond to the designated authorized healthcare for the certified pharmacy, and if different, require the pharmacy to recertify with a new authorized representative.
3. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: TIRF distribution and dispensing; certification of prescribers, pharmacies; enrolled patients; and audits of REMS participants. These records must be readily available for FDA inspections.
4. Establish a plan for addressing noncompliance with REMS program requirements.
5. Monitor prescribers, pharmacies, and wholesalers-distributors 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.
6. Annually audit all certified outpatient pharmacies, or a maximum of 400, that have received at least one shipment of a TIRF medicine in the past 12 months and 10% but no less than 50 certified inpatient pharmacies no later than 90 calendar days after they have become certified/re-certified in the TIRF REMS to ensure that all REMS processes and procedures are in place, functioning, and support the REMS Program requirements. Similarly, annually audit all wholesalers-distributors no later than 90 calendar days after they become authorized to distribute TIRFs to ensure that all REMS processes and procedures are in place, functioning, and support the REMS program requirements.
7. Take reasonable steps to improve operations of and compliance with the requirements in the TIRF REMS program based on monitoring and evaluation of the TIRF REMS program.