The misuse of opioids create a huge societal burden. According to the Food and Drug Administration (FDA), in 2010 over 16,500 deaths involved opioid use. In 2009 alone, the non-medical use of these drugs caused over 400,000 emergency department visits.
To combat this problem, the FDA released risk evaluation and mitigation strategies (REMS) to better educate prescribers and the public on the use of extended-release and long-acting opioids.
In a 2007 Act, the FDA was given authority to create management plans for drugs that carry serious risks. With REMS, the FDA can require a manufacturer of these classes of drugs to provide greater measures for safety to “ensure that the drug’s benefits outweigh its risks.” The extended release (ER) and long-acting (LA) opioid measures impact morphine, oxycodone, hydromorphone, oxymorphone, and tapentadol products. A full list of the opioid products required to have a REMS can be found on the FDA’s website.
The focus of the FDA’s REMS for opioid use is on prescriber and patient education. Companies who release ER/LA opioids are required to make educational materials available to all healthcare professionals who prescribe or work with ER/LA opioids, including physicians, nurse practitioners, physician assistants, and pharmacists.
These REMS materials include information on:
- Assessing patients for treatment with these drugs
- Initiating opioid use
- Discontinuing use of these opioids
- Managing and monitoring patients
- Counseling patients and caregivers about the safe use and risks of these drugs
- Recognizing evidence and potential for misuse, abuse, and addiction
Patients themselves also receive counseling documents and an updated Medication Guide to better help them manage their use of ER/LA opioids, along with advice on safe storage and disposal methods.
While the FDA means to prevent opioid abuse and misuse, patients with a legitimate need for opioid drugs will continue to have access to them.
Since the FDA’s release of these REMS guidelines in 2012, there has been research into the actual discussions being carried out between doctors and patients on the topic of opioid use. In a study published in Patient Education and Counseling, researchers found that doctors and patients with trusting relationships are in fact candidly discussing the risks and benefits of opioid use, with doctors providing advice on avoiding opioids and gathering additional information to better inform prescriptions.
Find out more about the FDA’s REMS program for ER/LA opioid use, along with answers to commonly asked questions, at the FDA’s website.
Image by Connor Tarter via Flickr