REMS Program


State and federal departments are working together to also develop increased education and training for patients taking opioid medications to improve safety and reduce the risk of abuse, one of these programs with which you may be required to comply is the REMS program.

Effective March 25, 2008, the Food and Drug Administration Amendments Act of 2007 (FDAAA) reserved the right for the U.S. Food and Drug Administration (FDA) to order Risk Evaluation & Mitigation Strategies (REMS) for drugs or biologics with significant toxicity levels and/or demonstrable risk factors.

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks.

The FDA has required a REMS for extended-release and long-acting (ER/LA) opioid analgesics.

Under the conditions specified in the REMS, patients who take analgesics are strongly encouraged to do all of the following:

1) Be educated on the safe use, serious risk, storage and disposal of opioid medication, which this course that I have created will teach you.

2) Obtain more specific information about the particular opioid medications you take by clicking on Patient Counseling Document (PCD).

3) Once on the PCD website click on Medication Guides and read the medication guide for the opioid medications you are taking. You should always be reading the Medication Guide that you will receive from your pharmacist every time an ER/LA opioid is dispensed to you, if you have not done so in the past.

Patient Counseling Document on Extended Release / Long-Acting Opioid Analgesics (English)