On October 13 and 14, 2021, the United States Food and Drug Administration (FDA) held a 2-day virtual public workshop to discuss mandatory opioid prescriber education as part of the Risk Evaluation and Mitigation Strategy (REMS). During the workshop speakers and panelists reviewed past programs that were put into place to reduce opioid prescribing, as well as trends in opioid prescribing and overdose deaths. They also extensively discussed what kind of education would be beneficial for providers and patients and the challenges that may arise from federally-mandated opioid prescriber education.
FDA’s Attempts at Curbing the Opioid Epidemic
In 2012, the FDA approved the Extended Release/Long Acting (ER/LA) REMS. The goal was to reduce serious adverse outcomes (addiction, unintentional overdose, and death) from inappropriate prescribing, misuse, and abuse of ER/LA opioid analgesics while maintaining patient access to pain medications. At the time, the ER/LA REMS required manufacturers to make education available, but in an effort to limit burden on the health care system and avoid impact on patient access, prescribers were not required to complete the education in order to prescribe.
In 2018, the REMS was expanded after further evaluation of the opioid epidemic to include immediate release opioid analgesics. The goal of the modified Opioid Analgesic REMS was to educate prescribers and other health care providers (including pharmacists and nurses) on the treatment and monitoring of patients with pain. It was intended to give the health care team an improved understanding of how to manage pain and the role of opioid analgesics along with nonpharmacologic and nonopioid analgesics in pain management. Although recommendations were made to make the training mandatory for prescribers, it remained voluntary.
Since 2012, the number of dispensed opioid prescriptions has steadily decreased in the United States from 81 prescriptions per 100 residents in 2012 to 47 prescriptions per 100 residents in 2020. There has also been a large decrease in the number of patients being prescribed high dose opioid analgesics, as well as in the dose prescribed to chronic users. However, overall opioid overdoses and opioid-involved deaths continue to increase, driven mainly by a rise in illicitly manufactured fentanyl and fentanyl analogues. Additionally, prescription opioid-involved overdose deaths increased during the COVID-19 pandemic, from a 12-month count ending in March 2020 of 74,680 overdose deaths to a 12-month count ending in February 2021 of 95,133 overdose deaths.
Considerations for Mandatory Prescriber Education
During the workshop, the panelists discussed the quantity and quality of opioid education available to prescribers as well as the potential gaps in knowledge. Many of the panelists noted the abundance of education that is available to prescribers trying to complete CME on opioid prescribing.
The gap often comes when prescribers are trying to taper opioid doses. Erin Krebs, a primary care physician at the Minneapolis Veterans Affairs Health Care System, relayed a story about a patient who wanted to get off opioids but his primary care provider was unsure on how to safely and effectively taper him off his medication. The patient was referred to a pain clinic where the pain specialist felt that suboxone might be helpful. The patient was sent to an addiction clinic, where the psychiatrist that evaluated him said that he did not qualify for opioid use disorder and could not be helped at the addiction clinic. Ultimately, this patient was sent in circles while trying to stop his opioids. Dr Krebs noted that it would be helpful to add educational material on how to properly taper opioids, as well as training on dependence, tolerance, withdrawal, and addiction.