New REMS for Opioid Disposal in the Works, and the FDA is Seeking Pharmacist Voices

The commentary urgently calls for pharmacists and pharmacy associations to offer the FDA their feedback on the SUPPORT Act and the potential for a new Risk Evaluation and Mitigation Strategy.

Pharmacists can play a key role in advocating for legislation that would create a more effective system of safe opioid disposal and mitigate problems of opioid misuse, according to a recent commentary.

Published in the Journal of the American Pharmacists Association,1 the authors highlighted the FDA’s recent discussions to determine if a new Risk Evaluation and Mitigation Strategy (REMS) is needed for opioid disposal. Investigators examined current issues regarding opioid use and safe in-home disposal, and evaluated if a proposed a funded mandate would be able to expand pharmacist engagement. 

The opioid crisis remains prevalent in the United States. Despite lower levels of opioid prescribing, 2020 marked the highest number of annual deaths from opioid overdoses, according to CDC data2—a record 100,000 people in the United States died from an opioid overdose during the pandemic. Less than half of patients with leftover prescription opioids dispose of them according to federal recommendations, the study authors reported. Pharmacists are positioned to provide valuable feedback on potential REMS improvements for opioids and mitigate opioid misuse.

The 2018 Public Law 115-271, or the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act—often called the SUPPORT for Patients and Communities Act3—in part allows the FDA to change some packaging systems and safe disposal measures for opioids through REMS. Currently, the FDA, Drug Enforcement Administration (DEA), and Environment Protection Agency (EPA) have outlined several disposal options, all voluntary: DEA takeback events, mail-back programs, and year-round permanent collection sites in local police stations, health care facilities, pharmacies, or other approved locations. 

However, “most patients are unaware of, confused by, or do not use any of the federally recommended opioid disposal options,” the authors wrote. According to a 2015 national survey of US adults who used opioid medications, 45.3% did not recall receiving resources on proper opioid disposal. Pharmacists were the primary source of information for patients on opioids with regards to safe and proper disposal (34.7% of respondents). 

The FDA is requesting insights from stakeholders to carve out a more robust REMS, including the American Pharmacists Association (APhA). The FDA already mandates an Opioid Analgesic REMS for outpatients and community-based health care to inform patients and caregivers of the risk of opioid addiction, which strongly encourages health care professionals to compete a REMS-compliant education program, “and counsel patients or their caregivers on the safe use, serious risks, and proper storage and disposal of their opioid prescriptions,” the authors explained. 

A potential new opioid REMS may impact pharmacists’ roles, services, and payment, researchers proposed. Section 6103 of the SUPPORT Act requires Medicare Advantage plans to provide enrollees with information of safe opioid disposal during an at-home risk assessment. In addition, Part D plans offer education to those enrolled in medication therapy management programs. Chapter 4 of the Act allows the FDA to mandate a REMS for safety and enhanced drug packaging and/or safety disposal systems for opioids. 

Study authors identified key areas of research needed to determine potential improvements and unintended consequences of a new REMS, including these questions:

  • What opioid products would be included in a new REMS?
  • Would special patient populations be described in the REMS, such as patients with acute or chronic pain, or both adult and pediatric patients?
  • Will all outpatient and community-based settings be included, such as community pharmacy and hospital discharge?
  • If part of a REMS, how often would a commercial in-home opioid disposal product or system need to be provided?

Investigators moreover introduced questions on the extent to which patients and caregivers should be counseled on at-home disposal options, and if these new requirements would “create an unfunded mandate or burden” on pharmacies.

The FDA may also consider solutions other than a new REMS, authored noted, including national public health campaigns that are supported by major pharmacy associations to bolster awareness of safe opioid disposal.

Research is necessary to explore the potential effectiveness of a new opioid disposal REMS. “No single definitive research approach exists to provide the evidence needed,” authors argued.

A new REMS would impact pharmacies on the basis of needed education and training and storage and potential distribution of special packaging or commercial in-home opioid disposal products. Authors recommended that the FDA or other stakeholders gauge receptivity from state regulation boards on these additional considerations, as well as create a cost analysis as part of its research on impacts or consequences.

The authors presented an urgent call to action for pharmacists and pharmacy associations to proactively engage with the FDA and other key stakeholders on the SUPPORT Act and a potential new REMS for opioid packaging. “To date, our professional has not leveraged the opportunity to provide necessary input on this. Issue,” authors concluded. 

References

1. Stubbings J, Crawford SY, Menighan TE. A safe in-home disposal system with every opioid prescription? FDA is considering a potential new risk evaluation and mitigation strategy that could impact pharmacists. J Am Pharm Assoc. Published online November 11, 2021. doi:10.1016/j.japh.2021.11.009

2. Dyer O. A record 100 000 people in the US died from overdoses in 12 months of the pandemic, says CDC. BMJ. Published online November 22, 2021. Doi:10.1136/bmj.n2865

3. SUPPORT for Patients and Communities Act, HR 6, 115th Cong (2018). Accessed November 24, 2021. https://www.congress.gov/bill/115th-congress/house-bill/6