Frequently Asked Questions

General FAQ's
Patient FAQ's
Prescriber FAQ's
Pharmacist FAQ's
Continuing Education & Grant FAQ's

 

General FAQ's

What is a REMS program and what is this REMS program?

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. FDA has determined that a single, shared REMS is required for all brand and generic extended-release (ER) and long-acting (LA) opioid (narcotic) pain medicines.

What pain medicines are included in this REMS program?

The branded and generic drug products subject to this REMS program include all of the following: extended-release, oral-dosage forms containing: hydromorphone, morphine, oxycodone, oxymorphone, or tapentadol; fentanyl and buprenorphine-containing transdermal delivery systems; and methadone tablets or liquid that are indicated for use as pain medicines.

What are the goals of this REMS program?

The goal of this REMS program is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse and abuse of ER/LA opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.

What are the components of this REMS program?

The central component of the ER/LA Opioid Analgesics REMS program is safety education/training for prescribers, patients, and their caregivers. For additional information see Prescribers, Pharmacists, and Patients FAQs on the ER/LA Opioid Analgesics REMS website at www.ER-LA-opioidREMS.com.

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

You can call the ER/LA Opioid Analgesics REMS toll-free number at 1-800-503-0784 to speak with a call center agent who can address general questions related to this REMS program or provide assistance with navigating through this REMS website.

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

You should call the ER/LA opioid analgesic company directly for product-specific questions. A listing of companies and products is on the ER/LA Opioid Analgesics REMS website available at www.ER-LA-opioidREMS.com. Click here for listing of products and company contact information.

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

Materials such as Medication Guides can be obtained from the following: at the pharmacy, accessed via a link on the REMS website at www.ER-LA-opioidREMS.com, or by contacting the company of the specific product directly. Additionally, the Patient Counseling Document is available on the REMS website.

What impact will this REMS program have on the healthcare system?

FDA has communicated the intent was to design and implement a REMS program without placing an unreasonable burden on the healthcare system or negatively impacting access to these necessary medications. The FDA is strongly encouraging completion of a REMS-compliant continuing education/training program by healthcare professionals in order to prescribe or dispense ER/LA opioid analgesics more safely and maintain patient access to pain medications.

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

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

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

Does not want call recorded

This call is recorded or monitored for quality assurance. Please know that all information you provide is confidential. We apologize for the inconvenience.

Literature Request

The REMS materials can be accessed via the website at www.ER-LA-opioidREMS.com.

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 ER/LA Opioid Analgesics REMS Program Companies ("RPC"), which is a collaboration of companies to implement a single shared REMS. The content on this website is determined by the RPC. This website is hosted on behalf of, and is financially supported by, the RPC. The domain name for this website was registered to Purdue Pharma L.P. on behalf of the RPC.

Is this website accessible through all search engines?

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

Who do I contact if I cannot access the website?

Contact the RPC call center at 1-800-503-0784.

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 RPC call center at 1-800-503-0784.

Where do I go to view the Medication Guides for the products covered under this ER/LA opioid analgesics REMS program?

The website at www.ER-LA-opioidREMS.com or call the manufacturer.

Where do I go to view the Full Prescribing Information for the products covered under this ER/LA opioid analgesics REMS program?

The website at www.ER-LA-opioidREMS.com or call the manufacturer.

How do I access, save or print any of the classwide 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 Document, the "Dear Prescriber" letter, the PCD Order Form. The REMS website has links to other documents, such as the FDA Blueprint, specific drug US Full Prescribing Information, and specific drug medication guides.

Who should I contact if I am having trouble viewing this website?

Please contact the RPC via phone at 800-503-0784 or email at erlaopioidrems@campbellalliance.com.

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

To view the Patient Counseling Document or the "Dear Prescriber" letter, or the PCD Order Form, you need to download the Adobe Acrobat viewer. This can be found at get.adobe.com/reader.

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Patient FAQ's

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

Call 911 or your local emergency service right away if: You take too much medicine, you 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 program?

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

What is the Patient Counseling Document?

The Patient Counseling Document explains how to safely use, store, and dispose of your used or unused extended-release and long-acting pain (opioid) medicine.  It also explains what to do if you are having any problems with your pain medicine.  This document should be given to you by your healthcare provider when they are writing you a prescription for an extended-release or long-acting pain (opioid) medicine.

What is the Medication Guide for this program?

The Medication Guide is a 1-page, 1-sided document that explains how to safely use, store, and dispose of your used or unused extended-release and long-acting pain medicine. The Medication Guide will include 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, ER/LA opioid analgesics 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 ER/LA Opioid Analgesics REMS website, under the "Medication Guides" tab. IFUs can also be requested by contacting the ER/LA opioid analgesics company directly. A listing of companies and products is on the ER/LA Opioid Analgesics REMS website available at www.ER-LA-opioidREMS.com. Click here for listing of products and company contact information.

Do I need to enroll in this program?

No, there is no enrollment required for patients.

Will this program affect my ability to get my opioid pain prescription?

This program should not affect your ability to receive your extended-release/long-acting opioid pain medicine that your healthcare provider has prescribed for you. One of the goals of this program is to help you understand how to use, store, and dispose of your used or unused medicine safely.

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

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 company that markets the specific product click here for listing of products and company contact information, or the Food and Drug Administration at 1-800-FDA-1088.

Is this REMS program going to keep these pain medicines from getting into the wrong hands, like teenagers and children?

One of the goals of this program is to educate patients on the safe storage and disposal of their opioid pain medicine in order to avoid anyone else taking the medicine that your healthcare provider prescribed only for you. You are strongly encouraged to report all side effects by contacting either of the following: the pharmaceutical company that markets the specific product click here for listing of products and company contact information, or the Food and Drug Administration at 1-800-FDA-1088.

One of my family members overdosed (had a serious injury/died) on a prescription pain medicine. How is this REMS program going to stop that from happening?

These medicines are strong prescription pain medicines that contain an opioid (narcotic) and have serious safety risks associated with them, especially if taken the wrong way or not as instructed by your healthcare provider. One of the goals of this program is to help you understand how to use, store, and dispose of your used or unused medicine safely in order to avoid overdose. You are strongly encouraged to report all side effects by contacting either of the following: the pharmaceutical company that markets the specific product click here for listing of products and company contact information, or the Food and Drug Administration at 1-800-FDA-1088.

I have difficulty swallowing pills. Is it okay to crush my extended-release or long-acting opioid pain medicine?

NO, do not break, chew, crush, dissolve, or inject your medicine. If you cannot swallow your medicine whole, talk to your healthcare provider.

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

According to FDA, flushing selected medicines down the sink or 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 program isn't available, FDA believes that any potential risk to people and the environment from flushing ERLA opioid analgesics is outweighed by the real possibility of life-threatening risks 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 program 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: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm#MEDICINES

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

You should contact the specific company of your ER/LA opioid analgesic. A listing of companies and products is on the ER/LA Opioid Analgesics REMS website available at www.ER-LA-opioidREMS.com. Click here for listing of products and company contact information.

Does my doctor have to be certified to prescribe me an extended-release opioid?

No, at this time this REMS program does not require your doctor to complete any new certification to prescribe extended-release opioids. However, all healthcare providers that prescribe extended-release long-acting opioids must be licensed by the Drug Enforcement Agency (DEA) and may have to meet other license requirements in their State.

What is the difference between extended release and immediate release opioid analgesics and their involvement in this REMS?

The immediate-release (IR) formulations are NOT subject to this REMS. According to the FDA description, IR opioid analgesics work for shorter periods of time. Extended-release (ER) opioid analgesics are designed to provide a longer period of drug release so that they can be taken less frequently. Long-acting (LA) opioid analgesics, such as methadone, have a longer period of action because of unique characteristics of the drug substance, which stays in the body for a longer time. 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 of time. Improper use of any opioid can result in serious side effects, including overdose and death, and this risk is magnified with 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?

This REMS and associated materials (e.g., PCD, MedGuides) only cover methadone (and buprenorphine) indicated for pain therapy. This REMS does NOT cover the addiction therapy indications. This program should not affect your ability to receive your extended-release/long-acting opioid pain medicine that your healthcare provider has prescribed for you. This program is designed to help you better understand how to safely use, store, and dispose of your used/expired or unused medicine.

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Prescriber FAQ's

What extended-release / long-acting (ER/LA) opioid analgesics are involved in this REMS program?

The branded and generic drug products subject to this REMS program include all of the following:  extended-release and long-acting, oral-dosage forms containing: hydromorphone, morphine, oxycodone, oxymorphone, or tapentadol; fentanyl and buprenorphine-containing transdermal delivery systems; and methadone tablets or liquids that are indicated for use as analgesics. Methadone and buprenorphine formulations indicated for treatment of addiction only are NOT subject to this REMS program.

Can you tell me more about the safety education/training intended for prescribers, such as myself?

REMS-compliant prescriber education/training is offered by accredited providers of continuing education (CE). You are strongly encouraged to complete a REMS-compliant CE/training activity from an accredited provider of CE to increase your knowledge in prescribing ER/LA opioid analgesic products more safely. CE credits are available for these activities. A listing of REMS-compliant CE activities can be found at: https://search.er-la-opioidrems.com/. This listing is updated regularly as Providers notify the RPC of new activities.

What important safety information will the education/training contain?

REMS-compliant, independent, accredited continuing education (CE)/training includes information on weighing the risks and benefits of opioid therapy, appropriate patient selection, managing and monitoring patients using extended-release and long-acting products, and counseling patients on the safe use of these drugs. The education/training, which is based on the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics, includes specific information deemed by FDA to be especially important about individual drug products in the ER/LA Opioid Analgesics REMS. Additionally, prescribers can learn how to recognize evidence of and potential for opioid misuse, abuse, addiction, and overdose.

How can I find out more about available REMS-compliant education/training and how to complete it?

REMS-compliant, independent, accredited continuing education (CE)/training activities supported by educational grants from the RPC are listed in a searchable table on the ER/LA Opioid Analgesics REMS website at https://search.er-la-opioidrems.com/Guest/GuestPageExternal.aspx, as they become available. The education/training first became available from CE/CME Providers at the end of February, 2013, and additional RPC-supported REMS-compliant CE activities are being posted to the searchable listing as CE Providers finalize details.

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

Health care professionals (HCPs) who prescribe ER/LA opioid analgesics are in a key position to balance the benefits of prescribing ER/LA opioid analgesics to treat pain against the risks of adverse outcomes. As such, health care professionals are strongly encouraged to complete REMS-compliant education/training offered by an accredited CE Provider.

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

One tool that this REMS program includes that is unique to the ER/LA Opioid Analgesics REMS, is the Patient Counseling Document, or PCD, on Extended-Release/Long-Acting Opioids. The PCD is designed to assist in having important conversations with patients for whom you select an ER/LA opioid analgesic. The PCD 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 ER/LA opioid analgesic safely. The PCD should be provided to your patient or their caregiver at the time you prescribe an ER/LA opioid analgesic for them.

Where can I go to access additional copies of the Patient Counseling Document (PCD)?

Access to the PCD and additional information on how to request multiple copies of the PCD is available on the ER/LA Opioid Analgesics REMS website at www.ER-LA-opioidREMS.com. Click here for PCD.

Why should I be interested in this REMS Program - 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. The goal of this REMS program is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse and abuse of ER/LA opioid analgesic products while maintaining patient access to these pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death. These outcomes are more likely to occur in patients at risk for abuse or misuse, as well as with accidental or intentional improper use.

Are there mandatory components associated with the ER/LA Opioid Analgesics REMS program that I must complete (eg, program enrollment, training), to allow me to continue prescribing ER/LA opioid analgesics to my patients?

Under this REMS, the companies of ER/LA opioid analgesics are required to make independent, accredited education/ training available to all ER/LA opioid analgesic prescribers and FDA has established performance goals related to the number of ER/LA opioid analgesic prescribers who must complete the education/training. While completion of REMS-compliant continuing education/training is not mandatory for individual prescribers under this REMS, all prescribers of ER/LA opioid analgesics are STRONGLY encouraged to successfully complete a REMS-compliant program from an accredited provider of continuing education (CE). Doing so will help to ensure safe use of these drugs, play an important role in addressing the growing national problem of abuse and misuse of prescription drugs, and help to achieve the goals of this REMS program. If this national problem is not addressed additional steps may need to be taken to restrict use of these drugs.

How are "Prescribers" defined in the ER/LA Opioid Analgesics REMS program?

Prescribers as referenced in this REMS program encompasses physicians, nurse practitioners, physician assistants, dentists, or any other health care professionals authorized by the Drug Enforcement Administration or their State to prescribe II or III drugs.

Do I need to complete more than one REMS-compliant education/ training if I prescribe multiple ER/LA opioid analgesics?

No. All of the REMS-compliant, independent, accredited continuing education/training activities will cover the full FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics and encompass all products covered under the REMS.

What if I have previously completed a/an [opioid, TIRF, Butrans, Embeda, Exalgo, Opana, OxyContin] REMS training, do I still need to complete additional education/training for the ER/LA Opioid Analgesics REMS program?

Accredited, REMS-compliant continuing education, which is based on the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics, was first made available on February 28, 2013.

HCPs 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 CE/training activity on the ER/LA Opioid Analgesics REMS content.

How often should healthcare providers participate in the ER/LA Opioid Analgesics REMS education/training?

Healthcare providers can avail themselves with the ER/LA Opioid Analgesics REMS education/training on a continuous basis.

How many CE/CME credits will a Healthcare Providers receive for completing the REMS education/training and how long will it take to complete?

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

What areas of education are contained in the FDA's ER/LA Opioid Analgesics REMS "Blueprint"?

FDA's Blueprint contains core messages for the safe use of these medications. Topics will include:

  • Why prescriber education is important
  • Assessing patients for treatment
  • Initiating therapy, modifying dosing, and discontinuing use
  • Managing therapy
  • Counseling patients and caregivers about safe use
  • General drug information
  • Specific drug information

A link to the FDA Blueprint will be available at: www.ER-LA-opioidREMS.com.

What are the responsibilities of the companies of ER/LA opioid analgesics as it pertains to prescriber education/training?

This REMS program requires that companies under the ER/LA Opioid Analgesics REMS ensure that REMS-compliant, independent, accredited education/training is made available to prescribers of these medications. All companies involved in this REMS-supported CE/training will adhere to the Standards of Commercial Support and, as such, the only involvement in the education/training will be as a grantor to support the education/training consistent with the FDA Blueprint.

Who is funding the REMS-compliant education/training?

REMS-compliant, independent, accredited education/training is funded by the REMS Program Companies (RPC), comprised of the companies who currently have ER/LA opioid products.

Where and how is the REMS-compliant education/training offered?

Detailed information about REMS-compliant education/training activities, including the location and format, is available via the REMS website at https://search.er-la-opioidrems.com/. A broad range of formats and venues for REMS-compliant 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/training?

There is no advanced certification associated with this education/training.

What happens if I do NOT participate in REMS-compliant education/training?

Under this REMS, the companies of ER/LA opioid analgesics are required to make independent, accredited education/training available to all ER/LA opioid analgesics prescribers and FDA has established performance goals related to the number of prescribers who must complete the education/training. While completion of REMS-compliant continuing education (CE) /training is not mandatory for individual prescribers under this REMS, all prescribers of ER/LA opioid analgesics are STRONGLY encouraged to successfully complete a REMS-compliant program from an accredited provider of CE. Doing so will help to ensure safe use of these drugs, play an important role in addressing the growing national problem of abuse and misuse of prescription drugs, and help to achieve the goals of this REMS program. If this national problem is not addressed additional steps may need to be taken to restrict use of these drugs.

Who is the target audience for the ER/LA Opioid analgesics REMS program?

At this time, the FDA has directed the ER/LA Opioid Analgesics REMS education/training towards prescribers.

How much will the education/training cost to participate?

FDA expects that the continuing education/training consistent with the FDA Blueprint will be developed by independent providers and will be offered to prescribers at no or nominal cost via educational grants supported by the ER/LA opioid analgesic companies.

Will the education/training content be the same regardless of format?

Yes, all REMS-compliant, independent, accredited continuing education/training supported by the companies involved in this REMS program must address all of the elements of the FDA Blueprint.

How long will the education/training be available?

REMS education/training will continue to be provided as long as the ER/LA Opioid Analgesics REMS is in effect.

Is there a deadline to complete the education/training?

While there is no deadline, you are encouraged to participate in the REMS CE/training 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 CE Provider for information on obtaining copies of CE credits.

How will the ER/LA Opioid Analgesics REMS program affect patient access to medications?

The ER/LA Opioid REMS is not expected to have any impact on patient access. The intent of this program is not to limit patient access to medication, but rather reduce serious adverse outcomes resulting from inappropriate prescribing, misuse and abuse of ER/LA opioid analgesic products.

What is the difference between extended release and immediate release opioid analgesics and their involvement in this REMS?

According to the FDA description, immediate-release (IR) opioid analgesics work for shorter periods of time. Extended-release (ER) opioid analgesics are designed to provide a longer period of drug release so that they can be taken less frequently. Examples of opioid analgesics formulated as both IR and ER products include hydromorphone, morphine, oxycodone, oxymorphone, and tapentadol. The IR formulations of these products are NOT subject to this REMS. 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 special design features 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 of time. Improper use of any opioid can result in serious side effects, including overdose and death, and this risk is magnified with ER/LA opioid analgesics. Please refer to the FDA website at http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm309742.htm#Q11 for additional information.

Will this REMS affect the prescribing and dispensing of methadone (or buprenorphine) indicated for addiction therapy?

There is no required change in the current prescribing or dispensing processes for methadone or buprenorphine for addiction-based therapies. This REMS and associated materials (e.g., PCD, MedGuides) only cover methadone (and buprenorphine) indicated for pain therapy, and does NOT cover the addiction therapy indications.

Will prescribers be required to be certified under this REMS to continue prescribing ERLA Opioid Analgesics?

No. Unlike other programs, this REMS is a Federal program, and at this time there is no certification requirement or connection to any state certification programs or requirements.

Where can I find the Patient Prescriber Agreement (PPA) referenced in the DHCP letter?

This REMS Program does not have a specific PPA that is recommended. However, there are several organizations that have templates available for your review to determine what is appropriate for your practice. Please refer to the websites for these organizations to obtain a sample PPA.

Will the content of CE activities be applicable to Vets or EMTs?

The CE activities will focus on the safe prescribing of ER/LA opioid analgesics and consist of core content as defined in the FDA Blueprint. While the primary target of this content is prescribers of ER/LA opioid analgesics as specified by FDA, the content may also be relevant for other healthcare professionals (e.g., pharmacists, veterinarians, emergency medical technicians). The CE provider determines the target audience based on needs assessment they conduct.

How do I report a Prescriber who misprescribes / over-prescribes ER/LA Opioid Analgesics?

The primary purpose of this call center is to assist with REMS-related questions on ER/LA 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 find the link to / locate the documents mentioned in / obtain an update on honorarium from the Prescriber Survey?

For inquiries regarding the Prescriber Survey, please call the ER/LA Opioid Analgesics REMS Call Center at 1-800-503-0784 to be directed to the Prescriber Survey Vendor.

I would like to update / remove my address for REMS mailings from the RPC.

Please call the ER/LA Opioid Analgesics REMS Call Center at 1-800-503-0784 and provide your current address [and new address] to the Call Center Agent.

Why did I receive / not receive the Dear DEA-Registered Prescriber Letter from RPC?

The letter was distributed to DEA-registered Prescribers on January 2013 and will be distributed to newly DEA-registered Prescribers annually in July moving forward. To be added / removed from the mailing list, please call the ER/LA Opioid Analgesics REMS Call Center at 1-800-503-0784.

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Pharmacist FAQ's

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

The central component of the ER/LA Opioid Analgesics REMS program is safety education/training for prescribers, patients, and their caregivers. Product-specific Medication Guides are a component of the ER/LA Opioid Analgesics REMS program. 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 ER/LA 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 program that impact inpatient or long-term care pharmacy practice?

No. There is no component of this REMS program 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 program impact the Medication Guides?

The layout of the Medication Guides for ER/LA opioid analgesics has been greatly modified by FDA in an effort to make them more understandable to the user. ER/LA opioid analgesics Medication Guides are now 1-page, 1-sided documents highlighting the drug's risks and safe use. ER/LA opioid analgesics that have additional "Instructions for Use" have not been impacted by this REMS program and continue to be available.

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 program. For products that have additional IFU, the IFU follows the Medication Guide available on the ER/LA Opioid Analgesics 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 company of the ER/LA opioid analgesic. A listing of companies and products is on the ER/LA Opioid Analgesics REMS website available at www.ER-LA-opioidREMS.com. Click here for listing of products and company contact information.

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

Instructions for Use (IFU) can be accessed via the ER/LA Opioid Analgesics website, via the "Medication Guides" tab. IFUs can also be requested by contacting the ER/LA opioid analgesic company directly. A listing of companies and products is on the ER/LA Opioid Analgesics REMS website available at www.ER-LA-opioidREMS.com. Click here for listing of products and company contact information.

Will pharmacists be required to complete education/training, enrollment, or verification to dispense these opioid analgesic products?

No. This REMS program does not require pharmacists in any pharmacy setting to complete additional education/training, verification, or enrollment to dispense ER/LA opioid analgesic products. However, outpatient or mail-order pharmacies are required to provide patients and/or their caregivers with the product-specific Medication Guide when dispensing an ER/LA opioid analgesic.

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

The ER/LA Opioid Analgesics REMS program 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 ER/LA opioid analgesics?

No. Even though FDA has required common opioid language within the Medication Guides, the Medication Guides for the ER/LA opioid analgesics subject to this REMS program 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 ER/LA opioid analgesic product.

How can pharmacists obtain the product-specific Medication Guides?

Each company 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:

If an ER/LA opioid analgesic previously had a Medication Guide [eg, Butrans, Embeda, Exalgo, Opana ER, OxyContin] - Can I continue to distribute those to patients?

Existing Medication Guides for ER/LA opioid analgesics will be replaced with new versions as they become available on the ERLA Opioid Analgesics REMS website at www.ER-LA-opioidREMS.com. Please check regularly as frequent updates will be made. Additionally, FDA has posted MedGuides on their website and can be located at: http://www.fda.gov/drugs/drugsafety/ucm085729.htm.

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 ER/LA opioid analgesic.

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

No. Company-generated drug information or CMI do 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 ER/LA opioid analgesic product dispensed.

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

Yes. Each ER/LA 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 ER/LA opioid analgesics, where can we refer patients?

Patients should have received and reviewed the "Patient Counseling Document" with their healthcare provider, which contains important safety information common to ER/LA opioid analgesics. Pharmacists will have product-specific Medication Guides to provide safe use information to patients. If patients are seeking additional information, they should be referred back to their healthcare provider who prescribed the medication. Patients can also visit the ER/LA Opioid Analgesics REMS website at www.ER-LA-opioidREMS.com for a review of Frequently Asked Questions for Patients; however, this should not take the place of speaking with their healthcare provider if they have a prescription for an ER/LA opioid analgesic .

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

The Patient Counseling Document reviews important safety information common to ER/LA 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 ER/LA opioid analgesic is dispensed.

Where should we refer patients who have product-specific questions?

Patients should be referred back to the healthcare provider who prescribed the medication. Patients can also contact the company of the ER/LA opioid analgesic if they have product-specific questions. Company and product contact information is available on the ER/LA Opioid Analgesics REMS website at www.ER-LA-opioidREMS.com. Click here for listing of products and company contact information.

Where should pharmacists report adverse events associated with ER/LA opioid analgesics?

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

What will prescribers and patients need to know about this REMS program?

The central component of the ER/LA Opioid Analgesics REMS program is safety education/training for prescribers, patients, and their caregivers.
Prescribers - Are strongly encouraged to complete a REMS-compliant CE/training program from an accredited provider of CE. Prescribers should also review and provide patients with the Patient Counseling Document.
Patients - The REMS will also include a Patient Counseling Document that prescribers can review and provide to patients to help them understand safe use and their responsibilities associated with using these products. Additionally, patients will be provided a product-specific Medication Guide when they receive their prescription for an ER/LA opioid analgesic at the pharmacy.

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

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

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

At this time, the FDA has directed the ER/LA Opioid Analgesics REMS education towards prescribers, but has also acknowledged that it may be relevant for other healthcare professionals (e.g., pharmacists).

The RPC recognizes that pharmacists are an important member of the patient care team, and as such, has supported a broadly-accessible online REMS-compliant educational activity that will be available by September 2013. Details will be posted to the RPC's listing of REMS-compliant educational activities on the ER/LA Opioid REMS website found at https://search.er-la-opioidrems.com/

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Continuing Education and Grant FAQ's

Where and how is the REMS-compliant education/training offered?

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

Is the education/training mandatory?

Under this REMS, the companies of ER/LA opioid analgesics are required to make independent, accredited education/ training available to all ER/LA opioid analgesic prescribers and FDA has established performance goals related to the number of ER/LA opioid analgesic prescribers who must complete the education/training. While completion of REMS-compliant continuing education/training is not mandatory for individual prescribers under this REMS, all prescribers of ER/LA opioid analgesics are STRONGLY encouraged to successfully complete a REMS-compliant program from an accredited provider of continuing education (CE). Doing so will help to ensure safe use of these drugs, play an important role in addressing the growing national problem of abuse and misuse of prescription drugs, and help to achieve the goals of this REMS program. If this national problem is not addressed additional steps may need to be taken to restrict use of these drugs.

How many CE/CME credits will a Healthcare Provider receive for completing the REMS education/training and how long will it take to complete?

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

What areas of education are contained in the FDA's ER/LA Opioid Analgesics REMS 'Blueprint'?

FDA's Blueprint contains core messages for the safe use of these medications. Topics will include:

  • Why prescriber education is important
  • Assessing patients for treatment
  • Initiating therapy, modifying dosing, and discontinuing use
  • Managing therapy
  • Counseling patients and caregivers about safe use
  • General drug information
  • Specific drug information

A link to the FDA Blueprint will be available at: www.ER-LA-opioidREMS.com.

Who is funding the REMS-compliant, independent, accredited education/training?

REMS-compliant, independent, accredited education/training is funded by the ER/LA opioid analgesic companies.

Will the independent, accredited, education/training content be the same regardless of format?

Yes, all REMS continuing education/training supported by the companies involved in this REMS program must address all of the elements of the FDA Blueprint.

Who can submit a grant application to support independent, accredited ER/LA Opioid Analgesics REMS prescriber education/training?

Any accredited CE Provider may apply by submitting a grant application that complies with the FDA Blueprint and the educational standards in the Request for Application (RFA) located at the ER/LA Opioid Analgesics REMS website at www.ER-LA-opioidREMS.com. The 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.ER-LA-opioidREMS.com.

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

All information related to the grant application process can be accessed at the ER/LA Opioid Analgesics REMS website at
www.ER-LA-opioidREMS.com.

Is there someone specific to contact if I should have questions about the grant application/process?

Questions regarding the grant application process can be directed through the ER/LA Opioid Analgesics REMS website at
www.ER-LA-opioidREMS.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 2013 Request for Application (RFA) contains additional information about the budget.

Are FDA and the REMS Participating Companies interested in being informed about non-RPC supported 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 REMS Participating Companies are interested in being informed about all non-RPC supported REMS compliant activities. Information will shortly be available at www.ER-LA-opioidREMS.com on how to submit information to the REMS Participating Companies.

How do I become an accredited CE provider so that I can provide ERLA Opioid Analgesics REMS training?

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

Which prescriber specialties should be included in the REMS-compliant training?

The CE activities focus on the safe prescribing of ER/LA opioid analgesics and consist of core content as defined in the FDA Blueprint. While the primary target of this content is prescribers of ER/LA opioid analgesics as specified by FDA, the content may also be relevant for other healthcare professionals (e.g., pharmacists, veterinarians, emergency medical technicians). The 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 FDA.

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

The MedBiquitous Working Group is in the final stage of completing both the MEMS Specifications and the MEMS Implementation Guidelines for REMS CE Data Exchange; however, both of these documents are still considered working drafts. The Specifications will proceed to the MedBiquitous Standards Committee for review by the Standards Committee, public review, and balloting.

While MEMS 2.0 will not be finalized until approved by the MedBiquitous Standards Committee, the draft Specifications, and MEMS Implementation Guidelines cover the information that Providers will need for collecting/reporting REMS CE data and can be referenced in their interim form.

When is the Grant Management System (GMS) open to accept grant applications?

Grant applications may be submitted to the GMS during the RPC’s periodic grant cycles. These cycles will occur at least annually and will be announced via the CE Provider section of the RPC website (click here) as well as the home page of the Grant Management System (click here). Further information regarding the GMS and the RPC grant cycle may be found on the CE Provider page (click here).

Who is responsible for verifying the percentage of doctors who complete the CE?

Accredited providers will report information on the number of participants to their respective Accrediting Body. The Accrediting Bodies will provide aggregate, de-identified data to a third party data base which will collate the information for reporting to the FDA.

How are the pharmaceutical companies going to prove to the FDA the number of doctors who completed the education?

Accredited providers will report information on the number of participants to their respective Accrediting Body. The Accrediting Bodies will provide aggregate, de-identified data to a third party data base which will collate the information for reporting to the FDA.

Would RPC-supported CE funding be available for military installations?

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

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

An accredited provider may partner/sponsor with an organization that is engaged in/represents healthcare professionals who provide direct patient care.

However, the grant request application must be submitted by the organization that is engaged in/represents healthcare professionals who provide direct patient care.

Is the RPC aware of any exclusions for prescribers who are federal medical personnel from participation in and receipt of certificates of completion for any CME/CE program supported under this initiative?

No, the RPC is not aware that any health professional is excluded from participating in any CME/CE program supported under this initiative.

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 CE provider submitting the application.

The eligible CE provider who submits the application selects partner(s) at its own discretion.

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

The duration of REMS-compliant CE training is at the discretion of the CE Provider; hence, there are no specific time limits on the training. The only requirement is that the training must address all elements of the 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 CE must be REMS-compliant, and will be evaluated based on all criteria outlined in the 2013 CE RFA, there are several criteria that are particularly important for Providers to consider.

    Essential Elements

  • Compliance with Provider eligibility requirements
  • Alignment -- clear "mapping" of proposed activity to the FDA Blueprint elements

    Elements of High Importance

  • Needs assessment specific to audience proposed by the Provider
  • Number of ER/LA opioid prescribers expected to complete activity(ies) covering full Blueprint plus assessment on all sections of Blueprint
  • Qualifications of Provider and partners
  • Educational design/methods (may include one or more)

Additionally, Providers must agree to uniform data submission procedure in accordance with MedBiquitous MEMS Implementation Guidelines for REMS CE Data Exchange.

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

Yes. While the entire content of the Blueprint must be addressed by the REMS-compliant CE training, Providers are encouraged to design CME 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 PCD and/or the FDA Blueprint for use in training materials?

Yes, the FDA Blueprint and Patient Counseling Document (PCD) are available for educational use by Healthcare Professionals who are involved in the dispensing of ER/LA opioid analgesics. These documents are available on the RPC Website at www.ER-LA-opioidREMS.com.

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

The best way to stay updated on the REMS-compliant CE activities is through the Continuing Education page on the RPC Website at www.ER-LA-opioidREMS.com.

Is a CE provider able to provide ERLA REMS education to doctors 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 training to be REMS compliant, training should contain core content as defined in the FDA Blueprint and may be subject to an audit.

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

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, Providers are encouraged to utilize the MedBiquitous standards to allow the data to be collected, aggregated and reported.

When will the revised MedBiquitous standard, which will enable the exchange of ER/LA opioid analgesic REMS CE outcomes data, be completed?

The revised Medical Education Metrics (MEMS) standard is currently in development and additional information will be forthcoming from MedBiquitous. Please refer to the MEMS 2.0 Summary on the MedBiquitous website at http://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 CE grants. What are the ways I can do this?

Medical Education Communication Companies (MECCs) are encouraged to partner with an eligible Provider, organization, or group of Providers/organizations and contribute to the REMS education through active collaboration.

The RPC appreciates all interest in REMS-compliant CE. We recognize that all Providers have a valuable contribution to make to this patient safety/public health initiative.

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