REMS for Opioids
Extended-Release and Long-Acting Opioids in Otolaryngology-Head and Neck Surgery
In April 2011, FDA announced the elements of a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of extended-release and long-acting (ER/LA) opioid analgesics outweigh the risks. The REMS supports national efforts to address the prescription drug abuse epidemic.
The goal of this REMS is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of extended-release or long-acting (ER/LA) opioid analgesics while maintaining patient access to pain medications. Adverse outcomes of concern include addiction, unintentional overdose, and death.
Click here to view the ER/LA REMS.
For a list of products covered under the ER/LA Opioid Analgesics REMS Program click here.
Under the conditions specified in this REMS, prescribers of ER/LA opioid analgesics are strongly encouraged to do all of the following:
- Train (Educate Yourself) - Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE).
- Counsel Your Patients - Discuss the safe use, serious risks, storage, and disposal of ER/LA opioid analgesics with patients and/or their caregivers every time you prescribe these medicines.
- Emphasize Patient and Caregiver Understanding of the Medication Guide - Stress to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an ER/LA opioid is dispensed to them to assist otolaryngology-head and neck physicians and surgeons, the AAO-HNSF is providing our members with the resources they need to educate themselves, their patients, and their caregivers on this critical topic.
Several health care organizations and medical specialty societies have developed REMS-compliant education programs. If you wish to participate in these programs please click here to see the complete list.
In order to assess the extent otolaryngology-head and neck physicians and surgeons prescribe ER/LA opioids, the Foundation would like your response to this one question, anonymous survey. The results will help determine if there is a greater need to provide education specific to our discipline. Thank you for taking the time to complete it.