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FDA Opioid Packaging Proposal: Experts Seek Proof of Concept

Posted 05 August 2019 | By Ana Mulero 

FDA Opioid Packaging Proposal: Experts Seek Proof of Concept

Comments on the US Food and Drug Administration’s (FDA) proposal for fixed-quantity unit-of-use blister packaging for certain opioid analgesics suggest the agency study its effectiveness in curtailing opioid abuse and potential consequences prior to implementation.
The comment period on the proposal to make certain opioid analgesics for acute pain treatment available in fixed-quantity unit-of-use blister packaging closed last week with upwards of 300 submissions. FDA says the goal of the proposal is to encourage more appropriate prescribing and reduce the number of unused opioids available for misuse or abuse.
The Association for Accessible Medicines (AAM), the United States Pharmacopeia (USP) and the American Pharmacists Association (APhA) recommend studying the proposal’s effectiveness in curbing opioid misuse and abuse as well as the potential consequences, whether intended or unintended, prior to implementing new requirements on application holders.
In its comments, AAM “urges FDA to examine the economics of blister packaging for manufacturers under the existing supply chain, and to conduct a study and present the results of the study regarding the actual effectiveness, or non-effectiveness of blister packaging curtailing opioid abuse.” The trade group argues this would provide “an approach that creates proof of effectiveness of curtailing opioid abuse, which could better justify the economics for manufacturers to make these changes.”
The argument rests on having a better understanding of real-world implications by studying the dynamics that pose difficulties in implementing the proposal without detracting from patient care. 
The agency has asked to hear about potential unintended consequences that could result from the proposal. The commenters raise concerns relating to an anticipated increase in manufacturing costs, which they say could adversely impact patient care and access.
The proposal could increase costs over having to transition to manufacturing lines that can support producing the opioid analgesic products in blister packs, argue AAM and APhA. “Packaging that is excessively costly or available through a small subset of distributors would also pose a challenge for pharmacies in obtaining such products,” APhA writes. With the potential of such unintended consequences, the groups urge FDA to consider the impact(s) on prescribing practices and patient care in studying its proposal.
According to the commenters, while there is research that supports fixed-quantity unit-of-use packaging to improve medication adherence, similar research is lacking with regards to curbing opioid misuse and abuse.
USP finds via stakeholder interviews that “manufacturers, wholesalers, and distributors are most concerned about potential financial impacts of packaging changes” that would be brought on by the proposal.
Costs increase are anticipated in the form of direct financial impacts, including the cost per unit and validation testing, as well as indirect financial impacts, including review times and sales.
“A change to unit-dose packaging likely has the most significant impact on manufacturers, due to the need to shift entire operations and manufacturing lines from bottling to novel unit-dose packaging, like blister packs,” USP writes. “If a change to unit-dose packaging is required, manufacturers may need a grace period to implement all changes to their packaging lines and to avoid supply shortages.” Clarification on whether the change will be optional is requested.
APhA suggests FDA pilot potential iterations of Risk Evaluation and Mitigation Strategy (REMS) requirements and implementation structures, identify different packaging designs and engage in user testing. AAM recommends FDA work with the Centers for Medicare and Medicaid Services to reset reimbursement of blister products and a 3-year grace period for REMS modifications.
The agency extended its REMS program for extended release and long-acting opioids to include all immediate-release opioid analgesics intended for outpatient use last September.


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