FDA seeks input on requiring fixed-quantity opioid blister packaging
The Food and Drug Administration has opened a public docket to solicit feedback to require that certain immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging.
The call for information follows the FDA’s implementation in recent months of new authorities Congress provided in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities, or SUPPORT Act to advance efforts to reduce unnecessary exposure to opioids and potentially lower the rate of new addiction.
The 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, as well as 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. The agency also is interested in hearing about the potential challenges associated with the proposal.
FDA acting commissioner Ned Sharpless, and Douglas Throckmorton, deputy director for regulatory programs-About the Center for Drug Evaluation and Research, issued a statement, noting that for many people addicted to opioids, their first opioid exposure was a prescription opioid, and 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 statement said.
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 statement said.
The statement continued, "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 statement said.
"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 statement said.
Earlier this month, the FDA 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 statement said.
The call for information follows the FDA’s implementation in recent months of new authorities Congress provided in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities, or SUPPORT Act to advance efforts to reduce unnecessary exposure to opioids and potentially lower the rate of new addiction.
The 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, as well as 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. The agency also is interested in hearing about the potential challenges associated with the proposal.
FDA acting commissioner Ned Sharpless, and Douglas Throckmorton, deputy director for regulatory programs-About the Center for Drug Evaluation and Research, issued a statement, noting that for many people addicted to opioids, their first opioid exposure was a prescription opioid, and 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 statement said.
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 statement said.
The statement continued, "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 statement said.
"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 statement said.
Earlier this month, the FDA 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 statement said.