It’s no secret that the FDA is looking at ways to stem the opioid crisis. Just a few months ago, the agency announced they were looking at what “forceful steps” they could take, established a steering committee and held a public meeting to evaluate the data they’re gathering.
This week, FDA Commissioner Gottlieb released a new statement, specifically calling out the potential that packaging holds. “To achieve these goals, one area we’ve committed to exploring further is how opioid drug products are packaged, stored and ultimately – when no longer needed – discarded. The FDA is committed to exploring our existing authorities to find new and impactful ways of regulating these product features to improve patient safety,” he said.
Gottlieb noted that the FDA is considering the following strategies:
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Packaging defined, short-term supplies of medication in a manner that limits the number of pills dispensed, which could be achieved through blister packaging.
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Packaging innovations that could make it easier to track the number of doses that have been taken.
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Improvements in storage and prompt disposal “to reduce the available supply and reduce the risk for third-party access, such as a child accidentally ingesting pills they found in a medicine cabinet. There are also technologies that could allow health care providers, pharmacists or family members to monitor patient use of prescription opioids.”
The Opioid Policy Steering Committee is also evaluating what steps the FDA may take with respect to packaging (e.g., unit of use) and has created an internal task force for research to be used in decision-making.
And what does the packaging industry have to say? “The opioid epidemic is a very serious public health issue and the packaging industry plays a critical role in developing solutions,” said Jim Pittas, Chief Operating Officer at PMMI, The Association for Packaging and Processing Technologies. “For years, machinery, materials and other suppliers in packaging have been at the forefront of new technologies for anti-tampering and product safety. This industry plays a vital role in producing robust packaging solutions to ensure the safety of consumers.”
Workshop
The FDA will hold a two-day public workshop Dec. 11-12, 2017 to help the evaluation, which will include “federal, state and other stakeholders who are also addressing the challenges of balancing pain management with the critical need to address the opioid epidemic.”
The goal of the meeting is to help define the following three areas:
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Specific problems that these types of packaging and disposal solutions can help address.
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The guiding principles that the scientific community should consider in designing product features that achieve these possible solutions.
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Types of data needed to evaluate how these solutions are working.
As the announcement noted, “We believe that innovation in packaging, storage, and disposal could have a meaningful impact on preventing or deterring misuse, abuse, or inappropriate access to prescription opioids – especially when coupled with additional efforts that the FDA and others are undertaking to reduce the scope of the opioid epidemic.”
