FDA Regulated Opioid Scripts

Opioid drug makers to fund education programs

/ Author:  / Reviewed by: Chris Galloway, M.D.

(RxWiki News) Opioid prescription drug abuse is being called an epidemic by the Obama administration. New education measures will be required at the expense of the drug manufacturers.

The US Food and Drug Administration (FDA) issued a press release that it has approved new safety measures for extended-release (ER) and long-acting (LA) opioid prescription medications. Measures should be in place by next spring.

"Follow dosage instructions and safely store all prescription medications."

In 2011, an estimated 22.9 million ER/LA opioid prescriptions were issued in the US.

In 2008, 14,800 Americans died from overdoses involving opioids. The number jumped to 15,597 in 2009, which is approximately four times the number in 1999.

The risk evaluation and mitigation strategy (REMS) for prescribing ER and LA opioids is designed to cut down on misuse and abuse of these drugs. They are labeling the state of prescription abuse as an epidemic.

Margret A. Hamburg, MD, the FDA commissioner, said, “Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge.”

“The FDA’s goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”

Part of the REMS will require drug companies that manufacture these ER/LA opioids to provide prescribing education programs for doctors based on FDA guidelines. This training should help doctors assess, manage and monitor patients more effectively.

FDA-approved patient education materials will also be required by the drug manufacturers to help the patients follow safety usage guidelines. This information should provide user-friendly information about use, dangers, storage and disposal of medication.

REMS will allow for the FDA to audit drug manufacturers for compliance with safety and education guidelines and give them the power to redesign the program if changes are warranted.

Training should be available for prescribers by March 1, 2013.

This press release was issued on July 9th and can be found on the US Food and Drug Administration website.

Reviewed by: 
Review Date: 
July 13, 2012
Last Updated:
January 7, 2013