This infrastructure will have the capacity for the storage and additional blister packaging equipment needed for unit dose packaging, which has become an integral part of dispensing opioid prescriptions as a way to prevent substance misuse.
A spokesperson for PCI told us that the recently passed national opioid legislation “encourages pharmaceutical companies in offering unit dose packaging forms in an effort to reduce the amount of drug dispensed in a prescription.”
In October 2018, US Food and Drug Administration (FDA) commissioner Scott Gottlieb issued a statement on how regulatory authorities will assist in addressing the opioid crisis. Per this statement, legislation will allow the FDA to require certain blister packaging, such as unit dose blister packs, for opioids and other drugs that pose a risk of abuse or overdose.
Gottlieb said, “These packs could then become the default option for more post procedure uses and could discourage physicians from prescribing long durations of use in situations where the evidence shows that short durations are clinically appropriate.”
“Ultimately, this approach could reduce the overall number of drugs in circulation and potentially lower the rate of new opioid addiction.”
Investment for anticipated demand
To prepare for the anticipated demand from the increased logistical requirements, following the legislation, the investment will see additional storage for controlled substances, as well as increased infrastructure for the complex manufacturing.
“Unit dose packaging for opioids requires the highest levels of the CPSC requirement for child resistant and senior friendly packaging. To achieve an F-1 rating, manufacturers need to utilize novel protective designs, of which PCI offers a full portfolio of solutions,” the spokesperson added.
Currently, the facility has dedicated approximately two million sq. ft. to packaging infrastructure across the two locations. The new capacity will be fully operational later on in 2019.
The company states that it has the immediate capacity for the introduction of unit dose blister packaging in formats that will meet the child-resistant requirements required for opioids. PCI stated that it has capacity positions to support more than 5bn unit dose blister packs annually. The investment will see an increase in capacity.
The company has expanded its onsite controlled substance storage at its US commercial packaging locations in both Philadelphia, PA and Rockford, IL. These two facilities may take on further expansions should demand increase for the specialized requirements the company can provide.