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 FDA Looks to Blister Packaging to Help Curb Prescription Opioids Abuse

Federal authorities want to use new powers given to them by recently approved legislation to “right size” more prescription opioids through the use of blister packaging, the type of dispensing method nursing facilities typically use in the course of caring for those in need of such pill-form medications.

In a statement announcing potential changes to how opioids are packaged, the Food and Drug Administration (FDA) said the agency has been implementing new authorities that Congress provided in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities—better known as the SUPPORT Act.

As part of the effort, FDA said it has been examining how patients are often prescribed significantly more opioid pills than they actually use following surgical procedures or other acute pain conditions for which opioids are prescribed.

Thus, the agency said it is focused on encouraging “right size” prescribing of opioid pain medication as well as reducing the number of people unnecessarily exposed to opioids, while also ensuring appropriate access to address the medical needs of patients experiencing pain severe enough to warrant treatment with opioids.

"The SUPPORT Act allows the FDA to require special packaging for opioids and other drugs that pose a risk of abuse or overdose,” the agency said. As a result, FDA said it has opened a public docket to solicit feedback on potential use of this new authority to require that certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging.

A skilled nursing profession advocate said on the overall issue of the appropriate use of opioids, it is important to pay attention to the quantities of drugs being dispensed, while also making sure the patient or resident is receiving medications they need in a timely fashion.

FDA said published studies show that most patients used significantly fewer pills than they were prescribed for many common minimally or less-invasive surgical procedures as well as some common acute pain conditions treated in the primary care setting.

“Specifically, most of these patients appeared to use opioids for only one to three days following surgery and took 15 or fewer pills. Patients reported that they usually retained unused pills in unsecure locations, providing opportunities for later misuse, abuse, accidental poisoning, overdose, and development of addiction,” FDA said.

Available data suggest that if 5-, 10-, or 15-count unit-of-use blister package configurations of certain commonly prescribed, immediate-release opioid pain medications were made available, one or more of these options could be expected to meet the needs of many patients experiencing acute pain.

The availability of these new packaging configurations could help prescribers to more carefully consider the amount of opioid pain medication they prescribe. These fixed-quantity unit-of-use blister packages could even become the default option for many common acute pain conditions for which opioid pain medications are commonly prescribed, where the evidence shows that shorter durations are clinically appropriate.

FDA stressed that these fixed-quantity unit-of-use blister packages would just be one option, and prescribers could continue to write opioid analgesic prescriptions in quantities they deem appropriate for their patients.

FDA said it would like comments on the potential public health impact of making fixed-quantity unit-of-use blister packages of certain opioid pain medications available for the treatment of acute pain among other issues. See more at www.fda.gov.

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