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 (PSLB) 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 (PSLB)" letter, you need to download the Adobe Acrobat viewer. This can be found at https://get.adobe.com/reader

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