The U.S. Food and Drug Administration (FDA) has announced new requirements for manufacturers of opioid analgesics (painkillers) dispensed in outpatient settings. The FDA is now requiring these manufacturers to provide prepaid mail-back envelopes as an additional option for patients to dispose of their opioid analgesics.
The FDA stated that all manufacturers of opioid analgesics used in outpatient settings must submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the notification letter.
The agency anticipates approval of the modified REMS in 2024. The new requirement aims to provide patients with a safe and convenient way to dispose of their unused or unwanted opioid analgesics. When implemented, outpatient pharmacies and other dispensers will have the option to order prepaid mail-back envelopes from opioid analgesic manufacturers, which they may then provide to patients prescribed opioid analgesics.
Moreover, the REMS modification also requires manufacturers to develop educational materials for patients on safe disposal of opioid analgesics. These materials will be provided to outpatient pharmacies and other dispensers, who may also provide them to patients.
Opioid analgesics are highly addictive and can lead to serious health consequences, including overdose and death. The agency believes that providing patients with safe and convenient options to dispose of their unused or unwanted opioid analgesics can help prevent diversion and misuse of these drugs. The FDA also notes that proper disposal of opioids is important in reducing the risk of accidental exposure.