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ICYMI: FDA Evaluating Packaging Changes to Immediate-Release Opioid Analgesics

The FDA announced last month that it is evaluating the public health and safety impact of modifying the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to have fixed-quantity blister-packaging. This would be for opioid analgesics used in treating acute pain.

As a recap, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) or HR 6, was a bipartisan bill passed in October of 2018. It provided additional resources for substance use disorder prevention, recovery, and treatment for patients and communities. Provisions in this law included developing non-addictive painkillers and establishing comprehensive opioid recovery centers. HR 6 also authorized four million dollars in grants to promote curriculum development on addiction and pain management in medical schools and residency programs to encourage new doctors to be more trained in the issue. Passage of this landmark legislation also gave the FDA several new authorities to address the opioid crisis.[1]

As directed by this law, the FDA is now reviewing the quantity of opioid pain medication given to patients following surgical procedures and for other acute pain conditions. This would modify the 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.”[2] The authority would be for those solid oral dosage analgesics prescribed to treat acute pain.

The FDA is currently soliciting feedback on this modification, specifically exploring different packaging, such as fixed- quantity blister packaging. Highly addictive drugs might be better suited for 5-, 10-, or 15-count unit-of-use packs. This type of packaging aims to address patients’ pain management needs while reducing the likelihood of unused drugs.

While it is ultimately up to prescribers to decide the clinically appropriate quantity of opioid pain medication for their patients, the FDA believes the fixed-quantity blister packs will encourage prescribers to more carefully consider the amount of medication given to a patient.

Fixed-quantity units will likely reduce the number of opioid analgesics given for patients following less-invasive surgical procedures or acute pain conditions. While the rate of opioid prescribing has gone down substantially, it is important to continue educating both prescribers and patients of the addictive properties of certain opioid analgesics.

Importantly, modifying the packaging could reduce the amount of unused opioid analgesics. Unused medications, that are not properly disposed of, pose an opportunity for misuse, abuse, inappropriate access, and overdose.[3]

The FDA has published a public docket for comment on the fixed-quantity unit-of-use blister packaging requirement for opioids. The FDA is also considering other potential modifications including mail-back pouches. This will provide helpful information regarding what products are appropriate for blister package configurations as well as potential challenges associated with the proposal.

Public comments are due either written or electronically on July 30th, 2019 here under Docket No. FDA-2019-N-1845.



[3] Ibid.

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