The US Food and Drug Administration (FDA) is seeking feedback from healthcare professionals on its proposal to offer fixed-quantity blister packaging for a select number of opioid medications.
This endeavor, undertaken in an effort to address the opioid crisis, is part of a multipronged approach that the agency has been pursuing over the past few years, with measures ranging from reducing exposure to opioids to supporting the development of novel therapies for pain.
In October 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act was passed in an effort to reduce the rate of new addictions to opioid medications by mitigating the risks for unnecessary exposure to these drugs. The FDA seeks to address the issue of “excess supply” of opioids (eg, from leftover pills prescribed for postsurgical pain) — shown to lead some individuals to develop addictive behaviors — by implementing what it terms “right size” prescribing.
On May 31, 2019, in a Federal Register notice, the FDA launched a “public docket” to collect feedback from healthcare professionals on the use of “unit-of-use blister packaging” of fixed quantity for immediate-release prescription opioids, in line with the SUPPORT Act.
In its statement, the agency cites evidence indicating that patients are often left with unused pills prescribed to manage pain following minimally invasive surgeries or acute pain, pills that are not always safely disposed of. Other studies indicate that if 5-, 10-, or 15-count ”unit-of-use blister packages” for some immediate-release opioids were available, these would be likely to provide adequate management of postsurgical and acute pain. Such blister packages would represent one of the options available to physicians, who could still prescribe opioids as needed.
The type of feedback the FDA is seeking regarding the use of these fixed-quantity unit-of-use blister packages includes foreseen impact on public health, nature of opioids to make this option available for, number of pills to include in packages, and anticipated challenges associated with such a measure.
“Our goal, through the step [we are] taking today and the many complementary actions [we are] taking to address the opioid crisis, is to promote more rational prescribing practices of opioids and reduce the rate of new addiction while maintaining appropriate access for patients who need these drugs,” noted the agency.
US Food and Drug Administration (FDA). Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids.
https://www.fda.gov/news-events/press-announcements/statement-fdas-request-information-requiring-fixed-quantity-blister-packaging-certain-opioid-pain?utm_campaign=053019_Statement_FDA%20requests%20information%20on%20fixed-quantity%20packaging%20for%20opioids&utm_medium=email&utm_source=Eloqua . Accessed May 30, 2019.