Frequently Asked Questions



What opioid analgesics are involved in this REMS?

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

  • Oral dosage forms containing: codeine and codeine analogs, hydrocodone, hydromorphone, levorphanol, meperidine, morphine, oxycodone, oxymorphone, pentazocine, tapentadol or tramadol
  • Intranasal butorphanol
  • Fentanyl transdermal delivery systems, buprenorphine buccal film and transdermal delivery systems indicated for use as pain medicines
  • Methadone tablets or liquid indicated for use as pain medicines

Can you tell me more about the opioid analgesic education intended for healthcare providers, such as myself?

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 from an accredited provider of CE 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.

What important safety information will the opioid analgesic education contain?

REMS-compliant, independent, accredited CE includes information on the basics of pain. The CE is based on the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring 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, identifying risk factors for abuse and addiction
  • 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
  • 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
  • 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

How can I find out more about available REMS-compliant accredited CE and how to complete it?

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.

Can you tell me more about the opioid analgesic education available for patients?

The Patient Counseling Guide is designed to assist healthcare providers in having important conversations with patients for whom you prescribe an opioid analgesic. The Patient Counseling Guide contains important safety information common to 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 Counseling 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.

Where can I obtain additional copies of the Patient Counseling Guide?

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

Why should I be interested in this REMS - what does it mean for me and my patients?

Opioid misuse and abuse, resulting in injury and death, has emerged as a major public health problem in the US. The goal of this REMS is to educate prescribers and other healthcare providers (including pharmacists and nurses) on the treatment and monitoring of patients with pain. The education provided through the REMS program is based on the FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain ("FDA Blueprint"). Through better education, the healthcare team will have an improved understanding of how to manage pain and the role of opioid analgesics along with nonpharmacologic and non-opioid analgesics in pain management. The education will also provide information about the risks of opioids and use of other therapies which is intended to assist healthcare providers in reducing adverse outcomes of addiction, unintentional overdose, and death resulting from inappropriate prescribing, abuse, and misuse. The REMS will accomplish this goal by:

  1. Ensuring that training based on the FDA Blueprint is effective in educating prescribers and other healthcare providers involved in the treatment and monitoring of patients in pain (including pharmacists and nurses) about recommended pain management practices and appropriate use of opioid analgesics.
  2. Informing patients about their roles and responsibilities regarding their pain treatment plan, including the risks of opioid analgesics and how to use and store them safely, as outlined in the Medication Guides and Patient Counseling Guide for opioid analgesics.

Are there mandatory components associated with the Opioid Analgesic REMS that I must complete (e.g., enrollment, education), to allow me to continue providing care or prescribing opioid analgesics to my patients?

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 broad 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 of these drugs.

How are "Providers" defined in the Opioid Analgesic REMS?

Providers as referenced in this REMS are prescribers such as physicians, nurse practitioners, 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. Providers also include members of the broad healthcare team who care for patients and/or their caregivers, such as nurses and pharmacists.

Do I need to complete more than one REMS-compliant accredited CE if I prescribe multiple opioid analgesics?

All opioid analgesic products intended for outpatient use are covered by this REMS. All the REMS-compliant, independent, accredited CE activities offered by or through the RPC 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"). All healthcare providers who prescribe opioid analgesics should take the necessary training they need to help ensure the safe use of opioid analgesics.

What if I have previously completed a/an [opioid, TIRF, Butrans, Embeda, Exalgo, Opana, OxyContin] REMS education? Do I still need to complete additional education for the Opioid Analgesic REMS?

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 of opioids and basic information about addiction medicine and opioid use disorders.

How often should healthcare providers participate in the Opioid Analgesic REMS-compliant accredited CE?

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.

How many CE credits will Healthcare Providers receive for completing the REMS accredited continuing education and how long will it take to complete?

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.

What areas of education are contained in the FDA's Opioid Analgesic REMS 'Blueprint'?

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:

Section 1: The Basics of Pain
  • Definitions and Mechanisms of Pain
  • Assessing Patients in Pain
Section 2: Creating the Pain Treatment Plan
  • Components of an Effective Treatment Plan
  • Non-Pharmacologic Therapies
  • General Principles of Pharmacologic Analgesic Therapy
    • Non-opioid analgesics and adjuvant mediations
    • Opioid Analgesics
  • Managing Patients on Opioid Analgesics
    • Initiating Treatment with Opioids - acute pain
    • Initiating Treatment with Opioids - chronic pain
    • Ongoing management of patients on opioid analgesics
    • Long-term management
    • How to recognize and intervene upon suspicion or identification of an opioid use disorder (OUD)
    • When to consult a pain specialist
    • Medically directed opioid tapering
    • Importance of patient education
  • Addiction Medicine Primer

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

What are the responsibilities of the companies of opioid analgesics as it pertains to healthcare provider education?

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").

Who is funding the REMS-compliant accredited CE?

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.

Where and how is REMS-compliant accredited CE offered?

Detailed information about REMS-compliant accredited CE activities, including the location and format, is available via the Opioid Analgesic REMS website at 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.

In addition to the CE credits is there any "advanced or additional certification" associated with the completion of this education?

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

What happens if I do NOT participate in 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 of these drugs.

Who is the target audience for the Opioid Analgesic REMS?

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, encompasses 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 analgesic.

How much will it cost to participate in the REMS-compliant accredited CE?

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 broad 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.

Will the education content be the same regardless of format?

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").

How long will the education be available?

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

Is there a deadline to complete the education?

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

Where may I get a copy of my CE credit?

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

How will the Opioid Analgesic REMS affect patient access to medications?

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 reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of opioid analgesic products.

What is the difference between extended-release, long-acting, and immediate-release opioid analgesics? When were IR opioids added to the Opioid Analgesics REMS?

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.

Will this REMS affect the prescribing and dispensing of methadone or buprenorphine indicated for treatment of opioid dependence?

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

Will healthcare providers be required to be certified under this REMS to continue prescribing opioid analgesics?

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

Will the content of accredited CE activities be applicable to veterinarians?

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.

Will the content of accredited CE activities be applicable to EMTs?

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.

How do I report a Prescriber who miss-prescribes / over-prescribes Opioid Analgesics?

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.

Where can I locate the documents mentioned in the Healthcare Provider Survey?

For inquiries regarding the Healthcare Providers Survey, please call the Survey Vendor at 1-800-497-9511.

How do I obtain an update on compensation from the Healthcare Provider Survey?

For inquiries regarding the Healthcare Providers Survey, please call the Survey Vendor at 1-800-497-9511.

How do I update / remove my address for REMS mailings from the RPC?

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.

Why did I receive / not receive the Dear Healthcare Provider Letter from RPC?

The letter was first distributed to healthcare providers within 60 calendar days of the approval of the REMS on 9/2018 and will be distributed to healthcare providers annually on the date of REMS approval moving forward. To be added / removed from the mailing list, please call the Opioid Analgesic REMS call center at 1-800-503-0784.

Are there Spanish versions of the Patient Counseling Guide or Medication Guides available?

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

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