Posted 20 April 2022 | By Joanne S. Eglovitch

The US Food and Drug Administration (FDA) proposed to modify its Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) program on Wednesday to require that a mail-back envelope be supplied along with prescriptions filled in the outpatient setting, so that unused opioids can be returned for disposal. Mail-back envelopes would be postage-paid.

The proposal aims to reduce the risk that unused pills will cause accidental overexposure or addiction.

“The FDA is committed to addressing the opioid crisis on all fronts, including exploring new approaches that have the potential to decrease unnecessary exposure to opioids and prevent new case of additions,” FDA Commissioner Robert Califf said in a statement. “As we explore ways to further address this issue more broadly, the mail-back envelope requirement under consideration for these unused medicines would complement current disposals programs and provide meaningful and attainable steps to improve the safe use and disposal.”

Unused opioid medications can create “unfortunate opportunities for nonmedical use, accidental exposure, overdose and potentially increasing new cases of opioid addiction,” said FDA.

Instead of disposing of these medications by mixing them with water, chemicals or other substances that are common with at-home disposal techniques, this proposal offers an alternative to ensure that opioids do not enter the water supply and landfills.

The plan complements other efforts to take back unused opioids, such as drug disposal kiosks in retail pharmacies and ‘take back’ days at pharmacies and public safety locations.

The potential burden of the plan is that pharmacists would have to complete REMS-mandated training and certification, as well as document compliance with the requirements.

FDA is interesting in getting comments on the following:

  • The potential safety advantages and public health impacts of providing mail-back envelopes;
  • Whether the plan should target more specific opioids analgesics, and if so, which products;
  • Whether the REMS should include a requirement for patient counseling

Agency officials have previously stressed that combatting opioid addiction is a priority. Patrizia Cavazzoni, the director of FDA’s Center for Drug Evaluation and Research (CDER) told a recent meeting that the agency’s FY 2023 budget request focuses on combating the nation’s opioid epidemic and improving postmarket surveillance. (RELATED: Cavazzoni discusses CDER staffing, FY2023 budget priorities, Focus regulators5 April 2022)

The deadline for commenting is 21 June.

FDA announcement

FDA notice

© 2022 Regulatory Affairs Professionals Society.


By admin

Leave a Reply

Your email address will not be published.