Frequently Asked Questions



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: https://www.fda.gov/drugdisposal

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 https://www.fda.gov/drugs/information-drug-class/opioid-analgesic-risk-evaluation-and-mitigation-strategy-rems 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.

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