FDA Proposes New Opioid Safety Initiative

The U.S. Food and Drug Administration (FDA) has announced a new initiative that may help reduce the potential for opioid abuse. The initiative opened for public comment on April 20 and would give patients prepaid envelopes to mail unused opioids back to the FDA.

According to the FDA’s entry into the Federal Register, the new initiative would “require opioid analgesics used in outpatient settings to be dispensed with prepaid mail-back envelopes and that pharmacists provide patient education on safe disposal of opioids.”

This will potentially provide another avenue to traditional opioid disposal methods such as using commercially available disposal products, collecting pills in collection kiosks, takeback events, and the environmentally-unfriendly method of flushing pills down the toilet.

After recovering from surgical procedures that require opioids, many patients report that they have opioids left over. These unused pills create what the FDA refers to as “unfortunate opportunities for nonmedical use, accidental exposure, overdose,” which potentially lead to new cases of addiction or potential deaths.

The FDA announcement notes that many consumers who become addicted to opioids are first exposed to the drug through friends or relatives who received opioids legitimately and then had some left over. Through this new mail-back initiative, the FDA hopes to reduce the number of opioids in patients’ homes, thereby curbing the potential for abuse.

In addition to convenience, the FDA lists a number of benefits to giving patients mail-back envelopes. First, they do not require the mixing of opioids with water or other substances, which is how purchasable opioid disposal products function. Second, opioids returned to FDA-registered facilities will not enter the water supply or be left in landfills. Third, the prepaid nature of the envelopes makes the process not only convenient, but free of charge.

The agency also noted that there are already preexisting regulations and policies in place to ensure that all mail-back envelopes can safely and securely transport unused medicines from the patient’s home to the location where they will be destroyed. The FDA hopes that the combination of education with convenience will increase the amount of opioids disposed, thereby reducing the number of easily abusable opioids available to consumers.

FDA Commissioner Dr. Robert M. Califf, M.D. stated, “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 cases of addiction.”

Dr. Califf added, “the mail-back envelope requirement under consideration for these unused medications would complement current disposal programs and provide meaningful and attainable steps to improve the safe use and disposal.”

The FDA will be accepting new comments on this proposed initiative until June 21, 2022.

The opioid epidemic has killed hundreds of thousands of consumers in the U.S. and has led millions to struggle with addiction, withdrawal, and overdose. While the FDA continues to pursue new and innovative methods to make opioids safer, hundreds of thousands of lawsuits have been filed against corporations and entities including Johnson & Johnson, Walgreens, Purdue Pharmaceuticals, and the Sackler family, the former owners of Purdue Pharma.

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