The U.S. Food and Drug Administration (FDA) is launching on April 25, 2019, its “Remove the Risk” campaign, aimed at promoting the safe disposal of unused opioids.1
Over 190 million prescriptions for opioids were filled in 2017 to over 60 million patients, and according to a systematic review of 6 studies published in JAMA Surgery, 42% to 71% of opioid tablets prescribed for the management of postsurgical pain may be unused, with low associated rates of disposal.2
The agency’s action plan involves 4 steps: reducing exposure to opioids and preventing new addiction — both of which can be partly addressed with mechanisms for safe disposal of unused opioids; supporting the treatment of opioid use disorder; fostering the development of novel pain medications, including the development of drugs that have no/low addictive profile; and improving drug enforcement as well as assessing the benefit/risk profile of available opioid medications.
Over half of individuals who misuse opioids are thought to acquire these drugs from a person in their circle who was left with unused pills, said Douglas Throckmorton, MD, deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research, when introducing the initiative on April 24, 2019. Many patients who are prescribed opioids do not use all of them, leading to millions of unused pills, and some of the patients are unaware of how to safely dispose of these drugs.
Opioids stored inappropriately represent a risk and may be accessible to anyone visiting the home. Intentional misuse of opioids is an important issue that the agency is intent on tackling. With this “Remove the risk” campaign, the FDA seeks to raise awareness on the risks associated with unused opioids. In particular, the campaign seeks to reach out to women aged 35 to 64 whom Dr Throckmorton says act as caregivers and “gatekeepers,” who can make sure that opioids stored in the home are safely secured or disposed of, in an effort to avoid serious health risks for adults, children, and pets.
Safest ways to dispose of unused medications, including opioids, is through medication take-back programs, available in pharmacies and law enforcement agencies. A decision tree infographic developed by the FDA provides information on how to safely dispose of unused opioids. Leftover drugs that are on the FDA’s “flush list,” which include buprenorphine, fentanyl, and hydrocodone, should be brought to a drug take-back location — a list of these locations is available on the Drug Enforcement Administration (DEA) website — whenever available. In the absence of such a location, drugs on the flush list should be immediately flushed in the toilet, recommends the FDA. Other drugs may be disposed of in household trash. Detailed instructions on safe drug disposal can be found here. The DEA is holding its annual national drug take-back day on Saturday, April 27, from 10 am to 2 pm.
As part of its toolkit, the FDA has produced video, radio, and print public service announcements, and encourages all to amplify its message by visiting the remove the risk website, using the hashtag #removeopioidrisk on social media, and is also asking for feedback on the materials included in the toolkit by contacting Morgan Jerrick, a health communications specialist at the FDA.
1. U.S. Food and Drug Administration. Safe opioid disposal – Remove the Risk Outreach toolkit. Available at: https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/ucm634961.htm?utm_source=other&utm_medium=content-text&utm_campaign=RemoveTheRisk. Accessed April 25, 209.
2. Bicket MC, Long JJ, Pronovost PJ, Alexander GC, Wu CL. Prescription opioid analgesics commonly unused after surgery: A systematic review. JAMA Surg. 2017;152(11):1066-1071.