Frequently Asked Questions



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://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.

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: FDA Blueprint

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 the Association of American Medical Colleges (formerly known as 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?

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/download_standards_and_guidelines#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.

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 CE RFA that was published for a given CE Grant Cycle, 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 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/download_standards_and_guidelines#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.

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 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).

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

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/download_standards_and_guidelines#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.

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.

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