In today’s prepublication of the Federal Register Notice entitled Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain (here), the Agency is opening a docket to receive comments on a requirement to blister package certain commonly prescribed opioid products in an effort to reduce the potential for over dispensing quantities of opioid products to be more consistent with historical patient need.
The Agency provides information relative to not only the most commonly prescribed prescription amounts but also the most common number of dosage units the patient typically consumes for the most common procedures or complaints. The data supports that the number of dosage units prescribed clearly exceeds the number of dosage units consumed from the prescription dispensed.
The Agency notes “[A]pproximately 89 percent of people who report misuse or abuse of prescription opioid pain relievers state they obtained their most recently used drugs from their own prescriptions or from a friend or relative”. Thus, the quantity of drugs historically originally dispensed is in excess of the quantity that the patient used for that episode of treatment.
The Notice discusses potential blister packaging that would provide “right-size” quantities more appropriate for treatment and also addresses revision of the opioid REMs program to potentially include proper disposal systems for the unused portion of any prescription.
The Agency recognizes that it must not disrupt supply or access to opioids but at the same time must take some action to address the looming opioid epidemic. The use of appropriate “right-size” blister packaging will aid in reducing excess opioids that may otherwise be prescribed, which at the same time may protect children from accidental overdose if the product is in child-resistant blister packaging.
The notice indicates 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))).” FDA is thus seeking comments on a number of issues that could impact its proposal, while at the same time permitting healthcare practitioners the ability to treat their patients appropriately. FDA recognizes that blister packaging may be one potential aid in fighting the opioid epidemic, but also recognizes that all opioid packaging may not be required to be in set quantity blister packaging.
FDA invites comment on the following topics (as well as others that will obviously be submitted). Please note that these are excerpts of the FDA’s comment topics, so please read the FR notice in its entirety for the full picture:
- Comment on the potential safety advantages and public health impact of broadly available, fixed-quantity unit-of-use blister packages of opioid analgesics for treatment of acute pain in adults.
- Comment on the specific IR opioid analgesic drug products for which it may be appropriate to require that blister packaging be made available, as well as the specific blister packaging configuration(s) it may be appropriate to require for each product or class of products, including the number of tablets or capsules to be included in the configuration(s).
- Comment on what specific information regarding the safe and effective use of opioid analgesics would be most beneficial to include in blister packaging configurations of these products.
- Comment on possible negative impacts of mandatory blister packaging, including any unintended consequences.
- Comment on the potential challenges, including technical and logistical challenges, with the potential blister packaging requirement.
- How much time would be needed for application holders to submit prior-approval supplements for blister packaging that would satisfy the proposed REMS requirements.
- Comment on the idea of implementing a blister packaging mandate in a staggered fashion, targeting the products most commonly prescribed to treat acute pain first, as well as the idea of imposing a conditional mandate for discontinued products.
- Comment on how the OA REMS modification could be designed and implemented to help ensure that required blister packaging is sufficiently available. Comment on the impact of any opioid analgesic blister packaging requirement on other stakeholders, including prescribers, payers, and pharmacies.
- As noted, FDA recognizes that the approach described in this notice is only one possible use of the Agency’s REMS authority concerning packaging. Comment on other possible uses of this authority.
The use of the new FDA authority in this regard can have significant impact on the industry and patients. Please be certain to review the FR Notice in its entirety to be certain to pose appropriate questions in response to this Notice. Cost impacts should also be addressed.