Call 911 or your local emergency service right away if:

• You take too much medicine
• Have trouble breathing or shortness of breath
• A child has taken this medicine

Your responsibility is to discuss with your healthcare provider the safe use, proper storage, and disposal of your pain medicine as described in the Patient Guide, and to read the Medication Guide that you will receive with your prescription at the pharmacy.

The Patient Guide explains how to safely use, properly store, and dispose of your pain medicine. It also explains what to do if you are having any problems with your pain medicine. This guide should be given to you by your healthcare provider when they are writing you a prescription for a pain medicine.

The Medication Guide is a document that explains how to safely use and dispose of your used or unused pain medicine. The Medication Guide includes important information specific to the pain medicine you were prescribed. This document is given to you when you receive your prescription from the pharmacy.

Some, but not all, pharmacies provide patients with additional information on how to safely use their medicine. This is known as the "Instructions for Use" and is generally provided to you with the Medication Guide.

Instructions for Use (IFU) can be accessed via the Opioid Analgesic REMS website under the "Medication Guides" tab. IFUs can also be requested by contacting the pain medicine manufacturer directly. A listing of companies and products is available on the Opio Analgesic REMS website available at www.opioidanalgesicrems.com. click here for listing of products and manufacturer contact Information

No, there is no enrollment required for patients.

This REMS should not affect your ability to receive your pain medicine that your healthcare provider has prescribed for you. One of the goals of this REMS is to help you understand how to use, properly store, and dispose of your pain medicine safely.

If you are experiencing a life-threatening medical emergency, dial 911 or your local emergency provider. If you experience a side effect, contact your healthcare provider for medical advice. You are also encouraged to report side effects to the FDA MedWatch program at 1-800-FDA-1088 or the pharmaceutical manufacturer.

This REMS helps to educate patients on the safe storage and disposal of their pain medicine in order to prevent anyone else from taking the medicine that your healthcare provider has prescribed only for you. This information, including safe disposal options, is available in the Patient Guide.

This REMS will help you understand how to use your medication properly. The REMS also includes important information about how to safely store and dispose of your medicine in order to avoid accidental overdose by others in the home.

There are some pain medicines that should never be broken, chewed, crushed, dissolved, or injected. If you cannot swallow your medicine whole, talk to your healthcare provider.

No, pain medicine patches containing opioid analgesics should never be cut.

According to the FDA, flushing certain medicines down the toilet is a safe way to immediately and permanently remove the risk of harm from the home. An alternative to flushing is to dispose the expired/unwanted/unused medicines through a medicine taKe back site or program, or by using a pre-paid drug mail-back envelope. When a medicine take-back site or program or pre-paid drug mail-back envelopes are not immediately available, the FDA believes that any potential risk to people and the environment from flushing pain medicines is outweighed by the real possibility of life-threatening harm from accidental ingestions of these medicines. You should contact your city or county government's household trash and recycling services to see if there is a medicine take back program in your community and learn about any special rules regarding which medicines can be taken !Jack. The FDA posts the dates for national-take-back day at: : https://www.fda.gov/drugdisposal .

You should contact the pharmacy that dispensed the medication.

No, at this time this REMS does not require your healthcare provider to complete any certification to prescribe pain medicine. However, all healthcare providers that prescribe opioids must be registered by the Drug Enforcement Administration (DEA) and may have to meet other license requirements in their State.

According to the FDA description, immediate-release (IR) opioid analgesics are formulated to release the drug over a shorter time period so they generally require more frequent dosing compared to extended-release opioid analgesics. Extended-release (ER) opioid analgesics are formulated to provide a longer time period of drug release so that they can be taken less frequently. Examples of opioid analgesics formulated as both IR and ER products include hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone, and tapentadol. Long-acting (LA) opioid analgesics, such as methadone, have a longer period of action because of the inherent characteristics of the drug substance, which stays longer in the body, and not because of the formulation of the finished product. The amount of opioid analgesic contained in an ER tablet can be much more than the amount of opioid analgesic contained in an IR tablet, because ER tablets are designed to release the opioid analgesic over a longer period.

On September 28, 2017, the FDA announced that IR opioids used in the outpatient setting are to Ile subject to the same REMS requirements as ER/LA opioid analgesics. Please refer to the FDA website at https:11www.roa.govtdrugsflnformat1on-drug-class/opiod-ana1gesic-risk-evaluation-and-m1ligation-strategy-rems for additional information.

It will not affect thOse prescriptions at all.

The branded and generic drug products subject to this REMS include all the following:

• Oral dosage forms conta n ng: code ne and codeine analogs, hydrocodone, hydromorphOne, evorphano , meperidine, morph ne, oxycodone, oxymorphone, pentazocine, tapentadol or tramadol
• Intranasal bulorphanol
• Fentanyl transdermal delivery systems, buprenorphine buccal film and transdermal delivery systems indicated for use as pain medicines
• Methadone tablets or liquid nd cated for use as pain medicines

REMS-compliant accredited CE for healthcare providers is offered by accredited CE Providers. You are strongly encouraged to complete a REMS-compliant accredited CE activity to increase your knowledge in prescribing opioid analgesic products more safely. CE credits are available for these activities. A listing of REMS-compliant accredited CE activities can be found at: https://www.opioidanalgesicrems.com/#Main/ActivitySearch. This listing is updated regularly as CE Providers notify the RPC of new activities.

REMS compliant, independent accredited CE includes information on the basics of pain. The CE is based on the FDA Opiod Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Mon tonng of Patients with Pain ("FDA Blueprint") . The core messages include:

• The fundamental concepts of pain management, including definitions and mechanisms of pain.
• How to assess patients in pain and identify risk factors for substance use disorders.
• The range of therapeutic options for managing pain, including nonpharmacologic approaches and pharmacologic (non-opioid and opioid analgesics) therapies.
• How to integrate opioid analgesics into a pain treatment plan individualized to the needs of the patient and evaluate for functional improvement.
• How to safely and effectively manage patients on opioid analgesics in the acute and chronic pain settings, including initiating therapy, titrating, and discontinuing use of opioid analgesics.
• How to counsel patients and caregivers about the safe use of opioid analgesics, including proper storage and disposal (e.g., in-home disposal systems, kiosks, take-back programs, pre-paid drug mail-back envelopes).
• How to counsel patients and caregivers about the use of naloxone for opioid overdose.
• When referral to a pain specialist is appropriate.
• The fundamental elements of addiction medicine.
• How to identify and manage patients with opioid use disorder.

REMS-compliant, independent, accredited CE activities supported by educational grants from the RPC are listed in a searchable table on the Opioid Analgesic REMS website at https://www.opioidanalgesicrems.com/#/Main/ActivitySearch, as they become available.

Other REMS-compliant accredited CE may also be offered by academic institutions or professional societies independent of RPC-related funding.

Healthcare providers (HCPs) who prescribe opioid analgesics and/or provide care to patients and their caregivers are in a key position to balance the benefits of prescribing opioid analgesics to treat pain against the risks of adverse outcomes. As such, healthcare providers are strongly encouraged to complete REMS-compliant accredited education offered by accredited CE Providers.

The Patient Guide is designed to assist healthcare providers in having important conversations with patients for whom they prescribe an opioid analgesic. The Patient Guide contains important safety and disposal information regarding the drug products subject to this REMS and includes space for you to write additional information to help your patients use their opioid analgesic safely. The Patient Guide should be provided to your patient or their caregiver at the time you prescribe an opioid analgesic to patients. The patient should also be given the specific drug’s Medication Guide when they pick up their prescription at the pharmacy.

Access to the Patient Guide and additional information on how to request multiple copies of the Patient Guide is available on the Opioid Analgesic REMS website at www.opioidanalgesicrems.com. Click here for the Patient Guide or Patient Guide order form.

The goal of the Opioid Analgesic (OA) REMS is to mitigate the risks of addiction, abuse, and misuse, which can lead to overdose and death. The Opioid Analgesic REMS is one of many national, state, and local efforts to address the misuse and abuse of prescription opioid analgesics.

The REMS will be assessed through these objectives:

1. Healthcare providers involved in the treatment and monitoring of patients in pain (including pharmacists and nurses) are educated on recommended pain management practices, including counseling patients and appropriate OA prescribing.
2. Patients are educated on the risks of OAs and the need for proper storage and disposal of OAs.
3. Patients are offered a safe disposal system as an option to safely dispose of unused OAs.

Under this REMS, pharmaceutical companies that manufacture or market opioid analgesics are required to make training available to all opioid analgesic prescribers and members of the broader healthcare team who provide care for patients and their caregivers. The companies are meeting this requirement by providing educational grants to accredited CE providers.

While completion of REMS-compliant accredited CE is not mandatory under this REMS, all healthcare providers are STRONGLY encouraged to successfully complete a REMS-compliant training program from an accredited provider of CE. Doing so may help to promote safe use and disposal of these drugs.

Providers as referenced in this REMS are prescribers such as physicians, nurse practitioners, physician assistants, and dentists, or any other healthcare providers authorized by the Drug Enforcement Administration or their State to prescribe scheduled II, III, and IV opioid analgesics.

Providers also include members of the broader healthcare team who care for patients and/or their caregivers, such as nurses and pharmacists.

No, all opioid analgesic products intended for outpatient use are covered by this REMS. All REMS-compliant accredited CE activities will cover the full FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint").

There has been new, updated training developed for this REMS. Healthcare providers are in a key position to balance the benefits of prescribing opioid analgesics against the risks of serious adverse outcomes. As such, you are strongly encouraged to complete a REMS-compliant accredited CE activity that is based on the updated FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint"). The "FDA Blueprint" includes content on pain management, including non-opioid alternatives. This includes principles related to management of acute and chronic pain; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic). The "FDA Blueprint" also covers information about the safe use and disposal of opioids and basic information about addiction medicine and opioid use disorders.

Taking a REMS-compliant accredited CE annually is strongly recommended. However, note that you will not receive CE credit for repeating the same CE course within the reporting period.

The number of CE credits for any particular activity will be determined by the accredited CE Provider. The number of credits and the length of time to complete the activity will depend on the scope and design of the educational activity.

The FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint") contains core concepts for the safe use of these medications. Topics include:

Section 1: The Basics of Pain

1. The Need for Comprehensive Pain Education
2. Definitions and Mechanisms of Pain
3. Assessing Patients in Pain

Section 2: Creating the Pain Treatment Plan

1. Components of an Effective Treatment Plan
2. General Principles of Non-Pharmacologic Therapies
3. General Principles of Pharmacologic Analgesic Therapy
   1. Non-opioid analgesics and adjuvant medications
   2. Opioid Analgesics
4. Managing Patients on Opioid Analgesics
   1. Initiating Treatment with Opioids - acute pain
   2. Initiating Treatment with Opioids - chronic pain
   3. Ongoing management of patients on opioid analgesics
   4. Long-term management
   5. How to recognize and intervene upon suspicion or identification of an opioid use disorder (OUD)
   6. When to consult a pain specialist
   7. Medically directed opioid tapering
   8. Importance of patient education including opioid storage and disposal
5. Addiction Medicine Primer

A link to the "FDA Blueprint" is available at: FDA Blueprint.

The Opioid Analgesic REMS requires that the manufacturers of opioid analgesics make training available to prescribers of these medications and other members of the healthcare team who provide care to patients and their caregivers. The companies are meeting this requirement by providing educational grants to accredited CE providers. All companies involved in this REMS-supported accredited CE will adhere to the Standards of Commercial Support and, as such, the only involvement in the education will be as a grantor to support the REMS-compliant accredited CE consistent with the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain("FDA Blueprint").

REMS-compliant, independent, accredited education is funded through educational grants by the REMS Program Companies (RPC), comprised of the companies who currently manufacture or market opioid analgesic products.

Detailed information about REMS-compliant accredited CE activities, including the location and format, is available via the Opioid Analgesic REMS website: https://www.opioidanalgesicrems.com/#Main/ActivitySearch. A broad range of formats and venues for REMS compliant accredited CE activities are being offered through the accredited CE Providers

The Opioid Analgesic REMS does not require advanced or additional certification associated with the REMS compliant accredited CE.

Under this REMS, the manufacturers of opioid analgesics are required to make independent, accredited CE available to all opioid analgesics prescribers and healthcare providers who provide care to patients and their caregivers. While completion of REMS-compliant accredited CE is not mandatory, all healthcare providers are STRONGLY encouraged to successfully complete a REMS-compliant CE activity from an accredited provider of CE. Doing so may help to promote safe use and disposal of these drugs.

At this time, the FDA has directed the Opioid Analgesic REMS accredited CE towards healthcare providers. This includes other members of the healthcare team who are involved in the management or support of patients with pain, such as nurses and pharmacists. "Prescribers," as referenced in this REMS, encompass physicians, nurse practitioners, pharmacists, physician assistants, dentists, or any other healthcare providers authorized by the Drug Enforcement Administration or their State to prescribe scheduled II, III, and IV opioid analgesics.

The FDA expects that REMS-compliant accredited CE consistent with the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint") has been developed by independent accredited CE Providers, and is offered to prescribers and members of the broader healthcare team who care for patients and their caregivers at no or nominal cost via educational grants supported by the RPC. Here is a link to the list of current accredited CE in a variety of platforms: https://www.opioidanalgesicrems.com/#/Main/ActivitySearch.

Yes, all REMS-compliant, independent, accredited CE supported by the companies involved in this REMS must address all the elements of the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint").

REMS-compliant accredited CE will continue to be provided as long as the Opioid Analgesic REMS is in effect.

While there is no deadline, you are encouraged to participate in the REMS-compliant accredited CE as soon as possible to help positively impact this important patient safety and public health issue.

The learner should contact the accredited CE Provider for information on obtaining copies of CE credits.

The Opioid Analgesic REMS does not impact patient access; the REMS does not impose any restrictions on prescribing or dispensing. The intent of this REMS is not to limit patient access to medication but rather to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of opioid analgesic products.

According to the FDA description, immediate-release (IR) opioid analgesics are formulated to release the drug over a shorter time period, so they generally require more frequent dosing compared to extended-release opioid analgesics. Extended-release (ER) opioid analgesics are formulated to provide a longer time period of drug release so that they can be taken less frequently. Examples of opioid analgesics formulated as both IR and ER products include hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone, and tapentadol. Long-acting (LA) opioid analgesics, such as methadone, have a longer period of action because of the inherent characteristics of the drug substance, which stays longer in the body, and not because of the formulation of the finished product. The amount of opioid analgesic contained in an ER tablet can be much more than the amount of opioid analgesic contained in an IR tablet because ER tablets are designed to release the opioid analgesic over a longer period. On September 28, 2017, the FDA announced that IR opioids used in the outpatient setting are to be subject to the same REMS requirements as ER/LA opioid analgesics. Please refer to the FDA website at https://www.fda.gov/drugs/information-drug-class/opioid-analgesic-risk-evaluation-and-mitigation-strategy-rems for additional information.

No. This REMS only applies to methadone and buprenorphine products indicated for the treatment of pain.

No. At this time, there is no certification requirement or connection to any state certification or requirements.

The Opioid Analgesics REMS accredited CE activities focus on the safe prescribing of opioid analgesics and consist of core content as defined in the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint"). While the primary target of this content is prescribers of opioid analgesics and healthcare providers who provide care to patients and their caregivers as specified by the FDA, the content may also be relevant for other healthcare providers (e.g., veterinarians). The accredited CE Provider determines the target audience based on the needs assessment they conduct.

The Opioid Analgesics REMS accredited CE activities focus on the safe prescribing of opioid analgesics and consist of core content as defined in the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint"). While the primary target of this content is prescribers of opioid analgesics and healthcare providers who provide care to patients and their caregivers as specified by the FDA, the content may also be relevant for other healthcare providers (e.g., emergency medical technicians). The accredited CE Provider determines the target audience based on the needs assessment they conduct.

If you have any concerns regarding a Prescriber, please contact your state's medical board or other local professional governing body (e.g., state pharmacy board) for assistance.

Please call the Opioid Analgesic REMS call center at 1-800-503-0784 and leave a message with your name, current address, action you wish to take, and new address (if applicable). If required, a Call Center Agent will return your call.

The letter was first distributed to healthcare providers within three months of the approval of the REMS modification on [Month/Year] and when pre-paid drug mail-back envelopes became available on March 31, 2025. It will also be distributed to healthcare providers annually on the date of the REMS approval moving forward. To be added or removed from the mailing list, please call the Opioid Analgesic REMS call center at 1-800-503-0784.

At this time, only the Patient Guide is available in Spanish. To access the Spanish version of the Patient Guide, please visit the Opioid Analgesic REMS website at www.opioidanalgesicrems.com.

The central components of the Opioid Analgesic REMS are REMS-compliant accredited CE for healthcare providers who prescribe these products and other healthcare providers who provide care to patients and their caregivers, including pharmacists, and a safe disposal system available to pharmacies and other dispensers of opioid analgesics. Product-specific Medication Guides are a component of the Opioid Analgesic REMS. Pharmacists in the outpatient and mail-order pharmacy setting are required to provide patients and/or their caregivers with the product-specific Medication Guide when dispensing an opioid analgesic. Medication Guides provide information in patient-friendly language about the drug’s risks and how to use the drug safely. Pharmacies and other opioid dispensing sites can now order pre-paid drug mail-back envelopes to provide their patients via the REMS website, www.opioidanalgesicrems.com, or by calling 1-800-503-0784.

No. There is no component of this REMS that specifically applies to inpatient or long-term care pharmacies. However, product-specific Medication Guides should be available and provided to inpatients upon request.

Distribution of a product’s Medication Guide has not changed as a result of this REMS. The product-specific Medication Guides are an element of the REMS and are part of approved product labeling. The Medication Guides can be used to facilitate communicating about aspects of safe use of opioid analgesics. Pharmacists in the outpatient and mail-order pharmacy setting are required to provide patients and/or their caregivers with the product-specific Medication Guide when dispensing an opioid analgesic.

Distribution of a product’s "Instructions for Use" (IFU) has not changed as a result of this REMS. The IFU is part of approved product labeling. For products that have additional IFU, the IFU follows the Medication Guide available on the Opioid Analgesic REMS website. The IFU should also be available in the product-specific packaging. Specific questions on a product’s IFU should be directed to the manufacturer of the opioid analgesic. A listing of companies and products is on the Opioid Analgesic REMS website available at www.opioidanalgesicrems.com. Click here for listing of products and manufacturer contact information.

Instructions for Use (IFU) can be accessed via the Opioid Analgesic REMS website, via the "Medication Guides" tab. IFUs can also be requested by contacting the opioid analgesic manufacturer. A listing of companies and products is on the Opioid Analgesic REMS website available at www.opioidanalgesicrems.com. Click here for listing of products and manufacturer contact information.

No. This REMS does not require pharmacists in any setting to complete accredited CE, enrollment, or verification to dispense opioid analgesic products. While completion of REMS-compliant accredited CE is not mandatory, all healthcare providers who provide care to patients and their caregivers, including pharmacists, are STRONGLY encouraged to successfully complete a REMS-compliant activity from an accredited CE provider. Outpatient and mail-order pharmacies are required to provide patients and/or their caregivers with the product-specific Medication Guide when dispensing an opioid analgesic.

The Opioid Analgesic REMS does not introduce new requirements for pharmacists. Pharmacists should continue to counsel patients in the same manner and follow existing state-specific regulations regarding patient counseling.

No. Even though the FDA has required common language in the Medication Guides for the opioid analgesics, the Medication Guides for the opioid analgesics subject to this REMS each contain product-specific risk information. Therefore, the appropriate and most current FDA-approved product-specific Medication Guide must be dispensed to the patient and/or caregiver with each specific opioid analgesic product.

Each manufacturer is responsible for providing Medication Guides in sufficient numbers to pharmacies in order to provide a Medication Guide to each patient receiving a prescription for the dispensed drug product. If additional Medication Guides are needed, they can be accessed via:

• The Opioid Analgesic REMS website at www.opioidanalgesicrems.com.
• Contacting the Opioid Analgesics REMS toll-free number at 1-800-503-0784 (a call center agent will then transfer you to the appropriate pharmaceutical manufacturer).
• Contacting the Opioid analgesic manufacturer directly as referenced on the Opioid Analgesic REMS website. Click here for a listing of products and manufacturer contact information.

The existing process for identifying the appropriate Medication Guide to dispense to a patient receiving any medication that has a Medication Guide has not changed. Each product-specific Medication Guide will continue to include the name of the manufacturer or distributor of the opioid analgesic.

No. Manufacturer-generated drug information or Consumer Medication Information (CMI) provided with your medication does not take the place of the Medication Guide. Pharmacists are responsible for providing patients and/or their caregiver with the product-specific FDA-approved Medication Guide for the opioid analgesic product dispensed.

Yes. Each opioid analgesic prescription must include a current product-specific Medication Guide with EVERY prescription, regardless of whether the patient has previously received the same medication. This is important because information may have changed since their last prescription.

Patients should have received and reviewed the Patient Guide with their healthcare provider, which contains important safety and disposal information common to opioid analgesics. Pharmacists have product-specific Medication Guides to provide safe-use information to patients. If patients are seeking additional information, they should be referred to their healthcare provider who prescribed the medication and/or their pharmacist. Patients can also visit the Opioid Analgesic REMS website at www.opioidanalgesicrems.com for a review of Frequently Asked Questions for Patients or the FDA’s Opioid Medications site at www.fda.gov/opioids . However, this should not take the place of speaking with their healthcare provider if they have a prescription for an opioid analgesic.

The Patient Guide reviews important safety and disposal information common to opioid analgesics and is provided by the healthcare provider to the patient at the time of prescribing the medication. Medication Guides are product-specific and include both common language regarding opioid risks and risks specific to the product. The Medication Guide is provided to the patient and/or their caregiver at the time the opioid analgesic is dispensed.

You are strongly encouraged to report all suspected adverse reactions associated with the use of the covered opioid analgesics by contacting either:

• FDA MedWatch program by phone at 1-800-FDA-1088 (1-800-332-1088) or online at www.fda.gov/medwatch/report.htm .
• The pharmaceutical manufacturer that markets the specific product (Manufacturer contact information available on the Opioid Analgesic REMS website). Click here for a listing of products and manufacturer contact information.

The central components of the Opioid Analgesic REMS are REMS-compliant accredited CE for healthcare providers who prescribe these products and other healthcare providers who provide care to patients and their caregivers, including pharmacists, and a safe disposal system available to pharmacies and other dispensers of opioid analgesics. Prescribers and other healthcare providers are strongly encouraged to complete a REMS-compliant accredited CE activity from an accredited provider of CE. The REMS also includes an education component for patients and/or their caregivers. The REMS includes a Patient Guide that healthcare providers who prescribe these drugs can review and provide to patients to help them understand safe use and disposal of opioid analgesics and their responsibilities associated with using these products. Additionally, product-specific Medication Guides are a component of the Opioid Analgesic REMS. Pharmacists in the outpatient and mail-order pharmacy setting are required to provide patients and/or their caregivers with the product-specific Medication Guide when dispensing an opioid analgesic. Medication Guides provide information in patient-friendly language about the drug’s risks and how to use the drug safely.

No. Distributors and wholesalers of opioid analgesics will not need to do anything new or different due to this REMS.

The FDA has directed that the Opioid Analgesic REMS education should be targeted towards prescribers, and other healthcare providers who care for patients and their caregivers (e.g., pharmacists and nurses).

The RPC recognizes that pharmacists are important members of the patient care team, and as such, supports broadly accessible online REMS-compliant accredited educational activities. Details are posted on the RPC’s listing of REMS-compliant accredited educational activities on the Opioid Analgesic REMS website at www.opioidanalgesicrems.com/#Main/ActivitySearch . Please check with your accrediting organization to find out about receiving CE credits.

Detailed information about REMS-compliant accredited CE activities, including the availability, location, and format, is available via the Opioid Analgesic REMS website at www.opioidanalgesicrems.com/#Main/ActivitySearch. A broad range of formats and venues for REMS-compliant accredited CE activities are being offered through the accredited CE Providers.

While completion of REMS-compliant accredited CE is not mandatory, healthcare providers are STRONGLY encouraged to successfully complete a REMS-compliant activity from an accredited provider of CE. Doing so may help to promote safe use of these drugs.

The number of CE credits for any particular activity will be determined by the accredited CE Provider. The number of credits and the length of time to complete the activity depend on the scope of the educational activity.

The FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint") contains core messages for the safe use of these medications. Topics include:

1. The Need for Comprehensive Pain Education
2. Definitions and Mechanisms of Pain
3. Assessing Patients in Pain

1. Components of an Effective Treatment Plan
2. General Principles of Nonpharmacologic Approaches
3. General Principles of Pharmacologic Analgesic Therapy
   1. Non-opioid medications
   2. Opioid analgesic medications
4. Managing Patients on Opioid Analgesics
   1. Initiating treatment with Opioids – acute pain
   2. Initiating Treatment with Opioids – chronic pain
   3. Ongoing management of patients on Opioid analgesics
   4. Long-term management
   5. How to recognize and intervene upon suspicion or identification of an Opioid use disorder (OUD)
   6. When to consult a pain specialist
   7. Medically directed opioid tapering
   8. Importance of patient education including opioid storage and disposal
5. Addiction Medicine Primer

A link to the "FDA Blueprint" is available at: FDA Blueprint .

REMS-compliant, independent, accredited CE is funded through educational grants by the opioid analgesic drug companies.

Yes, all REMS-compliant accredited CE supported by the companies involved in this REMS must address all of the elements of the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint").

Any accredited CE Provider may apply by submitting a grant application that complies with the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint") and the educational standards in the Request for Application (RFA) located on the Opioid Analgesic REMS website at www.opioidanalgesicrems.com. The accredited CE Provider may choose to collaborate with Educational Planner(s) to assist in the development and/or execution of an educational activity. All information related to the grant application process can be accessed at www.opioidanalgesicrems.com.

All information related to the grant application process can be accessed at the Opioid Analgesic REMS website at www.opioidanalgesicrems.com.

There will be a finite pool of resources available each year. The Request for Application (RFA) published on the Opioid Analgesic REMS website each year contains additional information about the budget.

Yes, the FDA and the RPC are interested in being informed about all non-RPC supported REMS-compliant accredited activities. Information is available at www.opioidanalgesicrems.com on how to submit information to the REMS Program Companies (RPC).

Go to the specific Accreditor's website for detailed information on the accreditation process. An alternative for participating in the provision of Opioid Analgesic REMS education may be to partner with an accredited CE Provider.

The accredited CE activities focus on the safe prescribing of opioid analgesics and consist of core content as defined in the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint"). While the primary target of this content is prescribers of opioid analgesics and healthcare providers who provide care to patients and their caregivers as specified by the FDA, the content may also be relevant for other healthcare providers (e.g., veterinarians or emergency medical technicians). The accredited CE Provider determines the target audience based on the needs assessment they conduct.

For purposes of qualification to request or receive an educational grant from the RPC, a provider must demonstrate that their enterprise is accredited by an organization recognized by the professional group for which credits are issued, that the accrediting body has standards they impartially employ to approve providers, and that the credits granted are accepted by appropriate licensing bodies for those professionals to recertify or maintain their license. The accrediting body must agree to provide reports of its activities to the third-party database aggregator in the format defined by the Association of American Medical Colleges (formerly known as MedBiquitous) for periodic reporting to the FDA.

Please reference the related MedBiquitous Specifications for a full list of REMS-related definitions, developed by the MedBiquitous Metrics Working Group, which has been updated as of January 06, 2021, and can be downloaded by registering or logging in to the following link: https://medbiq.org/activity_report .

Additional resources on activity reporting implementation guidelines and standards can be found via: https://medbiq.org/activity_report or https://www.medbiq.org/media/3206/download?attachment , which are now managed by the Association of American Medical Colleges.

The Grant Management System (GMS) will be updated periodically as new information is available from the FDA. The GMS can be accessed via the Opioid Analgesic REMS website: www.opioidanalgesicrems.com, and click "If you are an accredited Continuing Education Provider" link at the bottom of the right column.

Accredited CE Providers will report information on the number of participants to their respective Accrediting Body.

Accredited CE Providers will report information on the number of participants to their respective Accrediting Body.

Yes, organizations meeting RPC eligibility requirements who provide accredited CE to HCP's serving any branch of the US Armed Forces can apply for grant support for educational programming relevant to the Opioid Analgesic REMS.

An accredited CE Provider may partner/sponsor with an organization that is engaged in/represents healthcare providers who provide direct patient care. However, the grant request application must be submitted by the organization that is engaged in/represents healthcare providers who provide direct patient care.

There are no exclusions from participation by federal healthcare personnel. Certificates of completion may be provided upon request to the accredited provider of education.

The RPC eligibility requirements apply only to the primary accredited CE Provider submitting the application. The eligible accredited CE Provider who submits the application selects partner(s) at its own discretion.

The duration of REMS-compliant accredited CE is at the discretion of the CE Provider; hence, there are no specific time limits on the education. The only requirement is that the education must address all elements of the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint").

Grant requests/proposals should include any information required to succinctly and sufficiently convey all elements of the grant proposal. The Grant Management System specifications require that attachment files must be less than 10MB each; it is also recommended that grant proposals be formatted for printing on 8.5"x11" paper.

While all RPC-supported accredited CE must be REMS-compliant and will be evaluated based on all criteria outlined in the CE RFA that was published for a given CE Grant Cycle, there are several criteria that are particularly important for CE Providers to consider.

• Compliance with accredited CE Provider eligibility requirements
• Alignment – clear “mapping” of proposed activity to the updated FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint") components

• Needs assessment specific to audiences proposed by the accredited CE Provider
• Number of healthcare providers expected to complete activity/activities covering full updated “FDA Blueprint” plus completion of post-activity assessment
• Qualifications of accredited CE Provider and partners
• Educational design/methods (may include one or more)

Additionally, accredited CE Providers must agree to uniform data submission procedure in accordance with current MedBiquitous Specifications.

Please reference the related MedBiquitous Specifications for a full list of REMS-related definitions developed by the MedBiquitous Metrics Working Group, which has been updated as of January 28, 2019, and can be downloaded by registering or logging in to the following link: https://medbiq.org/activity_report .

Additional resources on activity reporting implementation guidelines and standards can be found via: https://medbiq.org/activity_report or https://www.medbiq.org/media/3206/download?attachment , which are now managed by the Association of American Medical Colleges.

Yes. While the entire content of the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint") must be addressed by the REMS-compliant accredited CE, Providers are encouraged to design CE programs that align with optimal adult learning principles and practices. If the FDA Blueprint is covered over multiple CE segments rather than one CE activity, an individual must complete all segments to be considered a REMS-compliant completer.

Total grant funding available will not be disclosed.

Yes, the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint") and Patient Guide are available for educational use by healthcare providers who are involved in the dispensing of opioid analgesics. These documents are available on the Opioid Analgesic REMS website at www.opioidanalgesicrems.com.

The best way to stay updated on the REMS-compliant accredited CE activities is through the Continuing Education page on the Opioid Analgesic REMS website www.opioidanalgesicrems.com.

A CE Provider is free to develop and offer education on this topic as well as others and does not need a grant from the RPC to do so. In order for the accredited CE to be REMS-compliant, education should contain all of the core content as defined in the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint"), be provided by an accredited CE Provider, and may be subject to an audit.

Accredited CE Providers receiving RPC grants under this REMS are required to report data utilizing the MedBiquitous Specifications. It is not within the RPC’s purview to advise on particular systems. For non-RPC supported CE, accredited Providers are encouraged to utilize the MedBiquitous Specifications to allow the data to be collected, aggregated, and reported (Please also reference CE FAQ #14, as appropriate).

Please reference the related MedBiquitous Specifications for a full list of REMS-related definitions developed by the MedBiquitous Metrics Working Group, which has been updated as of January 06, 2021, and can be downloaded by registering or logging in to the following link: https://medbiq.org/activity_report .

Additional resources on activity reporting implementation guidelines and standards can be found via: https://medbiq.org/activity_report or https://www.medbiq.org/media/3206/download?attachment , which are now managed by the Association of American Medical Colleges.

Medical Education Communication Companies (MECCs) are encouraged to partner with an eligible accredited CE Provider, organization, or group of CE Providers/organizations and contribute to CE education through active collaboration. The RPC appreciates all interest in REMS-compliant accredited CE. We recognize that all CE Providers have a valuable contribution to make to this patient safety/public health initiative.