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FDA exercising authority from SUPPORT Act to combat opioid crisis


06.06.19

WASHINGTON, DC The Food and Drug Administration (FDA) is requesting information for fixed-quantity blister opioid packaging as a potential means to help reduce the misuse and abuse of opioids. This authority and several new authorities were given to the FDA by  the SUPPORT for Patients and Communities Act, which was signed into law last year and is the single largest Congressional effort to tackle a drug epidemic in our nation’s history.

New authority being exercised by the FDA:

A recent announcement by the FDA requests feedback for implementing fixed-quantity blister opioid packaging. The FDA was given the authority in the SUPPORT Act to make drugs that have the potential risk of abuse to be placed in special packaging, such as fixed-quantity blister packaging. The special packaging would be in “unit-of-use blister package configuration.” It may come in multiples of five ranging from 5- to 15-count. However, the FDA is requesting comments for the ideal number of certain opioid pills for the various fixed packaging.

Behind the fixed-quantity blister packaging: 

Studies found in less-invasive procedures and common acute pain conditions most patients were not using all of the opioids prescribed. In fact, patients were often given significantly more than needed. The additional opioids open the door to potential addiction and overdose. The hope is that fixed-packaging will lead to less leftover opioids and reduce the risk of opioid addiction for the patient it was prescribed to or for a family member or friend that may find the excess opioids. If the fixed-quantity blister packing is implemented, this would not be the soleoption for a patient to receive an opioid prescription. Other prescription options would still be available when prescribers think different quantities should be prescribed for patients.

Feedback: 

The FDA requests feedback on the potential requirement of fixed-quantity blister opioid packaging to be submitted through the public docket, which can be found here. The information the FDA is interested in: the public health impact, opioid or opioid-containing products that would work well for the packaging requirement, potential number of pills in the packaging and challenges with the proposed requirement.

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