By 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
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, includi...
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