Statement from Acting FDA Commissioner Ned Sharpless, M.D. and Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA's Center for Drug Evaluation and Research, on FDA's request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids

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May 30, 2019, 09:34 ET

SILVER SPRING, Md., May 30, 2019 /PRNewswire/ -- The opioid tragedy has become one of the defining public health crises of modern times. As the rates of opioid addiction and overdose continue to grow, addressing the opioid crisis has taken on more urgency. For the past few years, the U.S. Food and Drug Administration has been focusing on decreasing unnecessary exposure to prescription opioids as a way to prevent new addiction; supporting the treatment of those with opioid use disorder; promoting the development of novel pain treatment therapies; increasing enforcement and carefully assessing the patient and public health benefits and risks of new opioid approvals.

In recent months, the agency has been implementing important new authorities that it sought and Congress provided in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities – better known as the SUPPORT Act. The new law will help advance efforts to reduce unnecessary exposure to opioids and potentially lower the rate of new addiction. We know that for many people addicted to opioids, their first opioid exposure was a prescription opioid. We also know that 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. This excess supply of opioids provides opportunities for misuse, abuse, overdose and development of addiction, as well as the potential for these leftover pills to end up in the hands of a child, friend or relative for whom they aren't intended.

The FDA's efforts to address the opioid crisis must focus on encouraging "right size" prescribing of opioid pain medication as well as reducing the number of people unnecessarily exposed to opioids, while 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. Today, the FDA is opening 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.

According to published studies 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.

The available data suggests 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 following a minimally or less-invasive medical procedure or other conditions commonly treated with opioid pain medications. 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. Reducing the amount of unnecessary opioid pain medication prescribed will lead to fewer pills left in medicine cabinets that could be inappropriately accessed by family members or visitors, including children, and could potentially lower the rate of new opioid addiction.

Importantly, 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.

The FDA is seeking feedback on the potential requirement outlined in today's Federal Register notice. Specifically, the agency 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. We'd also like feedback on which specific opioid or opioid-containing products are good candidates for blister package configurations as well the number of pills to be included in the configuration. We are also interested in hearing about the potential challenges associated with the proposal.

To further advance the goal of rationalized prescribing – and help reduce the rate of opioid over-prescribing – the SUPPORT Act also strengthens the FDA's current efforts to promote the development of evidence-based opioid prescribing guidelines for treating acute pain resulting from specific conditions or procedures. The FDA awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) in August 2018 to help advance the development of such guidelines. As part of this work, NASEM will scan the landscape of existing opioid analgesic prescribing guidelines and examine how these guidelines were developed and any potential gaps in evidence for those guidelines; it also will outline the research needed to generate that additional evidence. We've set a goal for work to be completed by the end of this year.

Earlier this month, we also launched a new awareness campaign called Remove the Risk designed to encourage patients to properly dispose of excess prescription opioids from their homes when they're no longer needed for their prescribed purpose.

Our goal, through the step we're taking today and the many complementary actions we're 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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Lyndsay Meyer, 240-402-5345, [email protected]
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SOURCE U.S. Food and Drug Administration