FDA Addresses Packaging and Storage as New Strategies for Opioid CrisisBy
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has outlined the use of packaging and storage of opioids as new strategies for how the FDA plans to reduce the scope of the opioid-addiction crisis.
Gottlieb issued a statement saying that exposure to opioids must be reduced to prevent more people from becoming addicted. “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,” he said in a statement. “The FDA is committed to exploring our existing authorities to find new and impactful ways of regulating these product features to improve patient safety.”
Gottlieb outlined some approaches in this regard. “For example, it’s possible that a defined, short-term supply of medication could be packaged in a manner that limits the number of pills dispensed. This might be achieved, for example, through a blister pack that has a defined duration of use that might be for only a limited number of doses. Other packaging innovations could make it easier to track the number of doses that have been taken. Still other options could work to improve storage and encourage prompt disposal to reduce the available supply and reduce the risk for third-party access, such as a child accidentally ingesting pills [he/she] found in a medicine cabinet. There are also technologies that could allow healthcare providers, pharmacists, or family members to monitor patient use of prescription opioids,” Gottlieb said.
The FDA has been working to explore solutions in this area. The Opioid Policy Steering Committee that the FDA established in May 2017 to solicit suggestions on the crisis is considering what steps the agency can or should take with respect to packaging (e.g., unit of use) to facilitate appropriate opioid analgesic prescribing practice. It has also created an internal task force that is conducting additional research to inform FDA policies and decision-making in these areas. Additionally, FDA staff are engaging with other experts to explore this topic, including participating in a workshop convened by the Duke-Margolis Center for Health Policy that generated additional ideas for further consideration.
Additionally, Gottlieb announced a two-day public workshop that will take place on December 11-12, 2017, to engage federal, state, and other stakeholders who are also addressing the challenges of balancing pain management with the need to address the opioid epidemic. “Our goals at this scientific workshop encompass three key areas,” Gottlieb said in his statement. “First, we need to define the specific problems that these types of packaging and disposal solutions can help address. Second, we want to more clearly define the guiding principles that the scientific community should consider in designing product features that achieve these possible solutions. Finally, we’ll better define the types of data needed in order to evaluate how these solutions are working,” Gottlieb said.
“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,” Gottlieb said.