Hydrocodone Bitartrate and Acetaminophen - Syneos Health

Opioid Analgesic Applicants must make training available to healthcare providers who prescribe and healthcare providers involved in the treatment and monitoring of patients who receive opioid analgesics.
The training must include all the elements of the FDA Blueprint. The training must be made available to healthcare providers who prescribe or are involved in the treatment and monitoring (including pharmacists and nurses) of patients who receive opioid analgesics.

Training is compliant with the REMS if it: 1) for training provided by Continuing Education (CE) Providers, is offered by an accredited CE Provider and supported by unrestricted educational grants from the opioid analgesic applicants; 2) includes all elements of the FDA Blueprint; 3) includes a knowledge assessment of all sections of the FDA Blueprint; and 4) is subject to independent audit to confirm that conditions of the REMS training have been met.

Opioid Analgesic Applicants must make a safe disposal system available to pharmacies and other dispensers of opioid analgesics intended for outpatient use.
To support the availability of a safe disposal system, Opioid Analgesic Applicants must:

1. Provide pre-paid drug mail-back envelopes that are compliant with 21 CFR 1317.70 upon request from pharmacies and other dispensers of opioid analgesics subject to the Opioid Analgesic REMS.
2. Include Patient Education Sheet with each pre-paid drug mail-back envelope.

To inform healthcare providers about the REMS and the risks and safe use of opioid analgesics, Opioid Analgesic Applicants must disseminate REMS communication materials according to the table below:

Target Audience	Communication Materials & Dissemination Plans
All DEA-registered prescribers, pharmacies, hospitals, and teaching institutions registered to prescribe or dispense Schedule II, III, and IV drugs	REMS Letter: Healthcare Provider Letter 1 or Professional Society/Licensing Board Letter 1 with attachment Patient Guide 1. Email by 01/10/2025 (i.e., 80 calendar days prior to launch of the MBE Program).         a. Send via mail by 01/10/2025 (i.e., 80 calendar days prior to launch of the MBE Program) if a healthcare provider’s email address is not available or the email is undeliverable.         b. Send a second email within 30 calendar days of the date the first email was sent if the first email is marked as unopened.         c. Send by mail within 30 calendar days of the date the second email was sent if the second email is marked as unopened.
	2. Disseminate through the following professional societies and request the letter or content be provided to their members:         a. The professional societies identified in Appendix A.
	3. Disseminate through all dental, medical (allopathic and osteopathic), nursing, and pharmacy licensing boards and request the letter or content be provided to their licensed practitioners.
	REMS Letter: Healthcare Provider Letter 2 or Professional Society/Licensing Board Letter 2 with attachment Patient Guide 4. Email within 30 calendar days of 03/31/2025 (i.e., after launch of the MBE Program).         a. Send by mail within 30 calendar days of 03/31/2025 (i.e., after launch of the MBE Program) if a healthcare provider’s email address is not available or the email is undeliverable.         b. Send a second email within 30 calendar days of the date the first email was sent if the first email is marked as unopened.         c. Send by mail within 30 calendar days of the date the second email was sent if the second email is marked as unopened.
	5. Disseminate through the following professional societies and request the letter or content be provided to their members.         a. The professional societies identified in Appendix A.
	6. Disseminate through all dental, medical (allopathic and osteopathic), nursing, and pharmacy licensing boards and request the letter or content be provided to their licensed practitioners.
All newly DEA- registered prescribers, pharmacies, hospitals, and teaching institutions registered to prescribe or dispense Schedule II, III, and IV drugs since the last dissemination	REMS Letter: Healthcare Provider Letter 2 with attachment Patient Guide 1. Email within 30 calendar days of 03/31/2026 and annually thereafter.         a. Send by mail within 30 calendar days if a healthcare provider’s email address is not available or the email is undeliverable.         b. Send a second email within 30 calendar days of the date the first email was sent if the first email is marked as unopened.         c. Send by mail within 30 calendar days of the date the second email was sent if the second email is marked as unopened.
All DEA-registered prescribers, pharmacies, hospitals, and teaching institutions registered to prescribe or dispense Schedule II, III, and IV drugs	Website Pop Up Message 1. Publish prominently on www.opioidanalgesicrems.com on March 31, 2025 and display for 180 calendar days. The Message must appear the first time a stakeholder logs into the website following launch of the message and require an active click to close it.

To support REMS operations, Opioid Analgesic Applicants must:

1. Establish and maintain a REMS website, www.opioidanalgesicrems.com. The REMS website must include a current list of training funded by the Opioid Analgesic Applicants that is REMS-compliant, 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 website. The REMS website must not link back to the promotional product websites.
2. Direct CE Providers to the FDA Blueprint on www.fda.gov/OpioidAnalgesicREMSBlueprint.
3. Make the REMS website fully operational and all REMS materials available through the website and call center by March 31, 2025.
4. Establish and maintain a REMS call center for healthcare providers at 1-800-503-0784.
5. Ensure healthcare providers who prescribe or are involved in the treatment and monitoring of patients who receive opioid analgesics are able to access training based on updated FDA Blueprint by October 31, 2024.
6. Ensure pre-paid drug mail-back envelopes are available to outpatient pharmacies and other dispensers of opioid analgesics upon request by March 31, 2025.
7. Ensure outpatient pharmacies and other dispensers of opioid analgesics are able to order pre-paid drug mail-back envelopes by phone and online.
8. Ensure that a Medication Guide is made available for dispensing with each opioid analgesic prescription.
9. Notify accredited CE Providers of REMS-compliant training regarding changes to the FDA Blueprint within 10 calendar days of such changes.
10. Use independent auditors (accreditation bodies of CE Providers are considered independent and eligible to conduct the audits) to audit the educational materials used by the accredited CE Providers of REMS-compliant training of a random sample of at least 10% of the training funded by the Opioid Analgesic Applicants to evaluate (1) whether the content of the training covers all the components of the FDA Blueprint, (2) whether the knowledge assessment measures knowledge of all sections of the FDA Blueprint, (3) whether the training was conducted in accordance with the standards for CE of the Accreditation Council for Continuing Medication Education or of another CE accrediting body appropriate to the prescribers, dental, pharmacy, nursing, or healthcare profession.