The Food and Drug Administration (FDA) is soliciting public comment on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that certain solid, oral dosage forms of immediate-release (IR) opioid analgesics commonly prescribed for treatment of acute pain be made available in fixed-quantity unit-of-use blister packaging for outpatient dispensing. This could reduce the amount of unused opioid analgesics, thereby reducing opportunities for misuse, abuse, inappropriate access, and overdose, and possibly reducing the development of new opioid addiction.
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), signed into law on October 24, 2018, provides FDA several new authorities to address the opioid crisis. The new law allows FDA to require certain packaging and disposal systems under a REMS for opioids and other drugs that pose a serious risk of abuse or overdose if, among other things, FDA determines that such packaging or disposal system may mitigate such risks (see section 505-1(e)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1(e)(4))). The purpose of this notice is to seek public comment on application of this new authority, including the potential application of this authority to require under the OA REMS that certain solid oral dosage forms of IR opioid analgesics commonly used to treat acute pain be made available in fixed-quantity unit-of-use blister packaging for outpatient dispensing.
FDA recognizes that the fixed-quantity unit-of-use blister packaging requirement the Agency is considering as part of the OA REMS is just one possible application of FDA's new authorities related to packaging and disposal. We are considering, and invite comment on, other potential mandates, including mail-back pouches or other safe disposal options. Furthermore, we actively encourage drug manufacturers and others to innovate in this space. We are aware of many promising packaging and disposal technologies that could have a positive impact on reducing misuse, abuse, inappropriate access, accidental poisoning, or overdose, or could otherwise facilitate the safe and appropriate use of prescription opioid analgesics. We believe that the potential packaging requirement outlined here could be a significant and readily achievable step towards improving the safe use of opioids, one that could be supplemented in the future by other safety-enhancing measures.