Frequently Asked Questions



What is a REMS and what is this REMS?

REMS stands for "Risk Evaluation and Mitigation Strategy". A REMS is a risk management program required by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks. The FDA has determined that a single, shared REMS, referred to as the Opioid Analgesic REMS, is required for all brand and generic opioid analgesics that are intended for use in the outpatient setting and not covered under another REMS.

Which pain medicines are included 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, tramadol
  • Intranasal butorphanol
  • Fentanyl transdermal delivery systems, buprenorphine buccal film and transdermal delivery systems indicated for use as pain medicines
  • Methadone tablets or liquid that are indicated for use as pain medicines

What is the goal of this REMS?

The Opioid Analgesic REMS is an educational effort and one of a number of national efforts that are designed to address the epidemic of prescription opioid abuse.

The goal of the Opioid Analgesic 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 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.

What are the principal components of this REMS?

The principal components of this REMS are:

  • REMS-compliant accredited CE for Healthcare Providers (HCPs), which includes all healthcare providers who prescribe or are involved in the management of patients with pain.
  • the Opioid Analgesics REMS Patient Counseling Guide, and
  • a Medication Guide for each opioid analgesic drug product.

For additional information visit the Opioid Analgesic REMS website at www.opioidanalgesicrems.com

Who can I call if I need to speak with someone about questions I have on this REMS?

You can call the Opioid Analgesic REMS toll-free number at 1-800-503-0784 for information regarding the most commonly asked questions regarding this REMS. If your specific question is not addressed, please leave a message, and a representative will return your call.

Who can I call if I have questions about a specific product?

You can talk to your pharmacist or call the individual opioid analgesic manufacturer directly for product-specific questions. A listing of companies and products is on the Opioid Analgesic REMS website available at www.opioidanalgesicrems.com.

What REMS materials are available for patient education? and how can I access them?

There are two documents available for patient education: the product-specific Medication Guide and the Patient Counseling Guide. The Medication Guides can be obtained from the pharmacy; accessed via a link on the Opioid Analgesic REMS website at www.opioidanalgesicrems.com; or by contacting the manufacturer of the specific product directly. The Patient Counseling Guide is available via a link on the Opioid Analgesic REMS website at www.opioidanalgesicrems.com.

Do I need to receive training about the safe use of opioid analgesics?

The FDA strongly encourages healthcare providers who prescribe or are involved in the management of patients with pain to complete a REMS-compliant accredited CE activity or other appropriate training in order to prescribe, dispense, or otherwise manage the use of opioid analgesics more safely.

How should an adverse event(s) associated with opioid analgesics be reported?

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, or
  • the pharmaceutical manufacturer that markets the specific product (Manufacturer contact information available on the Opioid Analgesic REMS website <click here for listing of products and manufacturer contact information>) Or, you may contact the Opioid Analgesic REMS call center at 1-800-503-0784 and leave a message and a call center representative will return your call

Privacy Statement -- What happens to the information I give you?

Call Center Communicators will take steps to safeguard any information you share with us and will not intentionally otherwise use or disclose any of your personally identifiable information, except to the extent reasonably necessary:

  • to correct technical problems and malfunctions, to technically process your information and to determine the effectiveness of our program;
  • to protect the security and integrity of our call center;
  • to protect our rights and property and the rights and property of others;
  • to take precautions against liability;
  • to the extent required by law or to respond to judicial process; or
  • to the enforcement agencies or for an investigation on a matter related to public safety or potential adverse event/product complaint, as applicable.

How can I obtain literature related to this REMS or the products in this REMS?

The REMS materials can be accessed via the Opioid Analgesic REMS website at www.opioidanalgesicrems.com Requests for literature for specific products may be made by contacting the pharmaceutical manufacturer that markets the specific product (Manufacturer contact information available on the Opioid Analgesic REMS website <click here for listing of products and manufacturer contact information>)

What is your confidentiality protocol?

The information that you provide to us is treated in a confidential manner. If necessary, the information may be transferred to member companies and the FDA as required by law.

Who owns this website?

This website is maintained by the Opioid Analgesic REMS Program Companies ("RPC"), which is a collaboration of drug product companies to implement a single shared REMS. The content on this website is determined by, hosted on behalf of, and is financially supported by the RPC.

Is this website accessible through all search engines?

This website is publicly available and should be searchable by most popular search engines.

Why is this website required by the FDA?

This website is required by the FDA to meet the REMS requirements.

Who do I call if I have questions, comments, or concerns about this website?

Contact the Opioid Analgesic REMS call center at 1-800-503-0784. You will have the option to leave a message, and a representative will return your call.

Where do I go to view the Medication Guides for the products covered under this Opioid Analgesic REMS?

The Opioid Analgesic REMS website at www.opioidanalgesicrems.com or call the manufacturer. Medication Guides are available on the Opioid Analgesic REMS website at www.opioidanalgesicrems.com or by calling the product manufacturer.

Where do I go to view the Prescribing Information for the products covered under this Opioid Analgesic REMS?

The Opioid Analgesic REMS website at www.opioidanalgesicrems.com or call the manufacturer. Medication Guides are available on the Opioid Analgesic REMS website at www.opioidanalgesicrems.com or by calling the product manufacturer.

How do I access, save or print any of the class-wide materials on the website?

Click on the link to the material and select "print" or "save" in your web browser.

What materials are available on the website?

The REMS materials available on the website are the Patient Counseling Guide, the Patient Counseling Guide Order Form, the Dear Healthcare Provider letters, and the Dear Professional Society and Licensing Board (DPSLB) Letters. The REMS website has links to other documents, such as 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 US Prescribing Information and Medication Guide for each drug included in the REMS.

What browsers and platforms are supported by this website?

The browsers supported by this website are Internet Explorer 8 or 9, Google Chrome v19, Safari 5, and Firefox v13. The platforms supported by this website are: Apple Mac OSX, Windows 7 PC, Android, iPhone OSX, and iPad OSX.

What do I do if I can't view some documents on the website?

To view the Patient Counseling Guide, the Patient Counseling Guide Order Form, the "Dear Healthcare Provider" letter, or the "Dear Professional Society and Licensing Board (DPSLB)" letter, you need to download the Adobe Acrobat viewer. This can be found at https://get.adobe.com/reader

BACK TO TOP
No matching records found.


What should I do if I take too much of my pain medicine?

Call 911 or your local emergency service right away if:

  • you take too much medicine,
  • have trouble breathing or shortness of breath, or
  • a child has taken this medicine.

As a patient, what am I required to do for this REMS?

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

What is the Patient Counseling Guide?

The Patient Counseling 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.

What is the Medication Guide for this REMS?

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.

What is the additional information following some of the Medication Guides?

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.

Where can I get another copy of the Instructions for Use?

Instructions for Use or, IFU, can be accessed via 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 on the Opioid Analgesic REMS website available at www.opioidanalgesicrems.com. <click here for listing of products and manufacturer contact information>

Do I need to enroll in this REMS?

No, there is no enrollment required for patients.

Will this REMS affect my ability to get my pain medicine?

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.

Who should I contact if I develop a side effect from my pain medicine?

If you are experiencing a life-threatening medical emergency, dial 911 or your local emergency provider. If you experience a side effect, you should contact your healthcare provider for medical advice. You are strongly encouraged to report all side effects by contacting either of the following: the pharmaceutical manufacturer that markets the specific product www.opioidanalgesicrems.com or the Food and Drug Administration at 1-800-FDA-1088.

How will this REMS improve the safe use of these pain medicines in my home?

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 is available in the Patient Counseling Guide.

How will this REMS reduce the risk of accidental overdose of prescription pain medicines?

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.

I have difficulty swallowing pills. Is it okay to crush my pain medicine?

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.

Is it okay to cut my pain medicine patch?

No. Pain medicine patches containing opioid analgesics should never be cut.

Is it really okay to flush my unused pain medicine down the toilet?

According to the FDA, flushing certain medicines down the toilet is currently the safest way to immediately and permanently remove the risk of harm from the home. An alternative to flushing is to dispose of the expired/unwanted/unused medicines through a medicine take back program. When a medicine take-back activity isn't 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 ingestion 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 activity in your community and learn about any special rules regarding which medicines can be taken back. The FDA posts the dates for national-take-back day at:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm

For additional information on the safe disposal of specific medications please contact the FDA at 1-888-463-6332 and visit the FDA's website at: https://www.fda.gov/drugdisposal

What is the best way to dispose of my unused pain medicine?

Please visit this FDA website for updated information on the safe disposal of opioids:

https://www.fda.gov/drugdisposal

Who should I contact if I see that my medication looks or smells different (i.e., broken pills, tear in patch, unusual smell/color)?

You should contact the pharmacy that dispensed the medication.

Does the REMS require that my healthcare provider be certified to prescribe pain medicine for me?

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.

What is the difference between extended release, long-acting, and immediate release pain medicines and their involvement in this 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

http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm309742.htm#Q11 for additional information.

How will this REMS affect my methadone or buprenorphine prescription for treatment of addiction?

It will not affect those prescriptions at all.

BACK TO TOP
No matching records found.


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: search.opioidanalgesicrems.com. 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 search.opioidanalgesicrems.com, 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: www.fda.gov/OpioidAnalgesicREMSBlueprint

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://search.opioidanalgesicrems.com 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://search.opioidanalgesicrems.com.

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/DrugSafety/InformationbyDrugClass/ucm163647.htm 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.

BACK TO TOP
No matching records found.


Are there components of this REMS that impact outpatient or mail-order pharmacy practice?

The central component of the Opioid Analgesic REMS is 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. 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.

Are there components of this REMS that impact inpatient or long-term care pharmacy practice?

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.

Did this REMS impact the Medication Guides?

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.

Am I required to provide the "Instructions for Use" with the Medication Guide?

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>

Where can I get a copy of the Instructions for Use?

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 directly. 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>

Will pharmacists be required to complete accredited CE, enrollment, or verification to dispense these opioid analgesic products?

No. This REMS does not require pharmacists in any pharmacy 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 and nurses, are STRONGLY encouraged to successfully complete a REMS-compliant activity from an accredited provider of CE. Outpatient or mail-order pharmacies are required to provide patients and/or their caregivers with the product-specific Medication Guide when dispensing an opioid analgesic.

Does this REMS require pharmacists to counsel patients on the safe use of opioid analgesics?

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.

Is there a single, shared Medication Guide we can use for all opioid analgesics?

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.

How can pharmacists obtain the product-specific Medication Guides?

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 # at 1-800-503-0784 (a call center agent will then transfer you to the appropriate pharmaceutical manufacturer), or
  • contacting the opioid analgesic manufacturer directly as referenced on this Opioid Analgesic REMS website <click here for a listing of products and manufacturer contact information>

How can I determine which product-specific Medication Guide is the correct one to dispense?

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.

Can manufacturer-generated drug information or consumer medication information (CMI) be provided to patients in place of the FDA approved Medication Guides?

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.

Does a Medication Guide need to be provided with each subsequent opioid analgesic prescription dispensed to the same patient, for the same product?

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.

If patients want to learn more about the safe use of opioid analgesics, where can we refer patients?

Patients should have received and reviewed the Patient Counseling Guide with their healthcare provider, which contains important safety 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 website 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.

How is the Patient Counseling Guide different from the product specific Medication Guides?

The Patient Counseling Guide reviews important safety 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.

Where should pharmacists report adverse events associated with opioid analgesics?

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, or
  • 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>)

What do healthcare providers and patients need to know about this REMS?

The central component of the Opioid Analgesic REMS is 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. Prescribers and the 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 Counseling Guide that healthcare providers who prescribe these drugs can review and provide to patients to help them understand safe use 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.

Will our distributors and wholesalers of opioid analgesics be affected by the REMS?

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

What if pharmacists are interested in reviewing REMS-compliant accredited CE? Can we also receive CE credit?

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 https://search.opioidanalgesicrems.com. Please check with your accrediting organization to find out about receiving CE credits.

BACK TO TOP
No matching records found.


Where and how is REMS-compliant accredited CE offered?

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

Is the education mandatory?

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.

How many CE credits will a Healthcare Provider receive for completing the REMS 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 depend on the scope of the educational activity.

What education topics are covered 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 Management
  • The Need for Comprehensive Pain Education
  • Definitions and Mechanisms of Pain
  • Assessing Patients in Pain
Section 2: Creating the Pain Treatment Plan
  • Components of an Effective Treatment Plan
  • General Principles of Nonpharmacologic Approaches
  • 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: www.fda.gov/OpioidAnalgesicREMSBlueprint

Who is funding the REMS-compliant, independent, accredited CE?

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

Will the independent, accredited, CE content be the same regardless of format?

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").

Who can submit a grant application to support independent, accredited Opioid Analgesic REMS healthcare provider education?

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.

If I am an accredited CE Provider, what is the process for applying for grant monies?

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

Is there a limit on the amount of funding for each grant request?

There will be a finite pool of resources available each year. Pages 8-9 of the 2018 Request for Application (RFA) contain additional information about the budget.

Are the FDA and the REMS Program Companies (RPC) interested in being informed about non-RPC supported accredited REMS compliant activities? If so, what is the process for a CE Provider who is interested in sharing information on a non-RPC supported REMS-compliant activity with the FDA and RPC?

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).

How do I become an accredited CE Provider so that I can provide Opioid Analgesic REMS education?

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.

Which healthcare provider specialties should be included in the REMS-compliant accredited CE?

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 needs assessment they conduct.

What qualifies as an equivalent accrediting body?

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 license. The accrediting body must agree to provide reports of its activities to the third-party database aggregator in the format defined by MedBiquitous for periodic reporting to the FDA.

What is the status of the MedBiquitous standards that are designed to support the reporting of REMS CE data?

The MedBiquitous Working Group updated both the Medical Education Metrics (MEMS) Specifications and the MEMS Implementation Guidelines for REMS CE Data Exchange. The Specifications will proceed to the MedBiquitous Standards Committee for review by the Standards Committee, public review, and balloting.

The MEMS 2.0 can be found at the following links, the Specifications (http://groups.medbiq.org/medbiq/display/MWG/Specifications+and+Schemas), and MEMS Implementation Guidelines (https://medbiq.org/sites/default/files/files/MEMSImplementationGuidelines.pdf) cover the information that Providers will need for collecting/reporting REMS CE data and can be referenced.

When will the REMS be ready to accept grant applications?

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: Go to www.opioidanalgesicrems.com, and click "If you are an accredited Continuing Education Provider" link at the bottom of the right column.

Who is responsible for verifying the percentage of healthcare providers who complete the accredited CE?

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

How will the REMS Program Companies (RPC) prove to the FDA the number of healthcare providers who completed the education?

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

Is RPC-supported continuing education (CE) funding available for military installations?

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.

May CE RFA response submissions be submitted by an accredited CE Provider as long as the submitter has, as a joint sponsor or subcontracted partner, an organization that is engaged in or represents healthcare providers who provide direct patient care?

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.

Are there any exclusions from participation in and receipt of a certificate of completion for any CE program supported under this initiative for healthcare providers who are federal healthcare personnel?

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

Is it acceptable to have an associate from Canada as part of an application since the application process states that only providers from the US and its possessions may apply?

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.

Are there time requirements for the REMS-compliant accredited CE? That is, may education last more than 3 hours?

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").

Is there a limit on the number of pages associated with the CE Grant Proposal? Are there certain requirements for the proposal as to font, layout, etc.?

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.

Is there a points system of any kind for approving grants?

While all RPC-supported accredited CE must be REMS-compliant, and will be evaluated based on all criteria outlined in the 2018 CE RFA, there are several criteria that are particularly important for CE Providers to consider.

Essential Elements Elements of High Importance
  • 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 MEMS Implementation Guidelines for REMS CE Data Exchange (Full text found here: https://medbiq.org/sites/default/files/files/MEMSImplementationGuidelines.pdf)

May the FDA Blueprint Elements be covered over multiple CE segments rather than in one CE activity?

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.

How much grant money is available?

Total grant funding available will not be disclosed.

Are CE Providers allowed to print the Patient Counseling Guide and/or the FDA Blueprint for use in education materials?

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 Counseling 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.

How can I get updates regarding the REMS-compliant accredited CE?

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.

Is a CE Provider able to provide REMS education to healthcare providers without applying for a grant?

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.

Are there particular applications that should be used to meet the qualifications for reporting of RPC-funded accredited CE activities? What about for non-RPC funded activities?

Accredited CE Providers receiving RPC grants under this REMS are required to report data utilizing the MedBiquitous standards. 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 standards to allow the data to be collected, aggregated and reported (Please also reference CE FAQ #14, as appropriate).

When will the revised MedBiquitous standard, which will enable the exchange of Opioid Analgesic REMS accredited CE outcomes data, be completed?

Please refer to the MEMS 2.0 Summary on the MedBiquitous website at https://medbiq.org/mems_20_summary for additional information and updates.

I represent a Medical Education Communication Company (MECC) and wish to be involved with REMS-compliant accredited CE grants. What are the ways I can do this?

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 the REMS 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.

BACK TO TOP
No matching records found.