REMS name changed to Opioid Analgesic REMS. REMS modified to:

1. Include immediate-release (IR) opioid analgesics intended for use in an outpatient setting
2. Ensure that training is made available to healthcare providers involved in the treatment and monitoring of patients with pain (including nurses and pharmacists)
3. Implement an updated FDA Blueprint for Healthcare Provider (HCP) Education which requires the education to cover broader information about appropriate pain management.

1. Incorporate information regarding the use of OxyContin in the pediatric population.
2. Add information to the titration recommendations of OxyContin for adult patients.
3. Add product-specific information for a recently approved ER/LA opioid analgesic, MorphaBond (morphine sulfate extended release) tablets.
4. Add product-specific information for a recently approved ER/LA opioid analgesic, Belbuca (buprenorphine) buccal film.

1. Incorporate information regarding use of OXYCONTIN in the pediatric population
2. Add information to the titration recommendations for adult patients.

1. Change the ER/LA Opioid Analgesics REMS Blueprint for Prescriber Education to incorporate:
1. Product-specific information for a recently approved ER/LA opioid analgesic, Hysingla ER (hydrocodone bitartrate extended-release) tablets.
2. Newly approved intermediate strengths of fentanyl transdermal systems.
3. Revised titration information for Dolophine (methadone HCl tablets).

1. Incorporate the following safety labeling changes to the ER/LA Opioid Analgesics REMS Blueprint, ER/LA opioid analgesic REMS Website, and the Dear Prescriber Letter (DHCP) letter:
1. New indication for ER/LA opioid analgesics.
2. New warning for Neonatal Opioid Withdraw Syndrome (NOWS).
3. Updated language for the following Warnings and Precautions:
1. Addiction, Abuse, and Misuse
2. Life-Threatening Respiratory Depression
3. Accidental Ingestion
4. Cytochrome P450 3A4 Interaction (for applicable products)
4. Revisions to the Blueprint to incorporate updated product-specific titration language.
2. Change the ER/LA Opioid Analgesics REMS Blueprint to include product-specific information for ER/LA opioids approved after the last ER/LA REMS modification on April 15, 2013

1. Revise Section VI. Specific Drug information for ER/LA Opioid Analgesic Products of the FDA Blueprint.
2. Revise the REMS Website, including the landing page and the webpage listing covered products under the REMS program.
3. Revise the individual product Medication Guides for relevant drugs.
4. Revise the REMS document to remove ANDA holders from the Timetable for Submission of Assessments.

1. Add Nucynta ER REMS product information to the shared system.
2. Make technical corrections to the Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (FDA Blueprint).