https://framinghamsource.com/index.php/2021/07/17/senators-markey-braun-re-introduce-the-safer-prescribing-act-legislation-to-require-warning-label-on-opioid-medications/

WASHINGTON DC – On July 15, Senators Edward J. Markey (D-Mass.) and Mike Braun (R-Ind.) re-introduced two pieces of legislation to help combat the opioid epidemic by improving awareness of the risks associated with prescription opioids.

The first bill, the Safer Prescribing of Controlled Substances Act, requires prescribers of opioid medications to complete additional training on responsible prescribing practices and substance-use disorder treatment.

The second bill, the Lessening Addiction by Enhancing Labeling (LABEL) Opioids Act, calls for labeling of prescription opioid bottles with a consistent, clear, and concise warning label on the potential of the drugs for dependence, addiction, or overdose.

The LABEL Opioids Act would exempt opioids approved by the Food and Drug Administration (FDA) for treatment of opioid-use disorder, like methadone and buprenorphine, from the labeling requirement.

“Prescription opioids continue to lead far too many individuals down the path of addiction and dependence,” said Senator Markey. “If providers are going to prescribe these potentially ruinous drugs, they should also be able to identify when a patient may be dealing with an opioid-dependence issue and inform the patient of treatment options. These two pieces of legislation will help ensure patients and providers make responsible and informed decisions when it comes to prescription opioids.”

“The opioid epidemic only got worse during the COVID-19 pandemic, and given that a serious opioid addiction can affect anyone, we need solutions like these two bills which ensure that all opioid pill bottles have a clear and concise warning label about the possibility of dangerous drug dependence and require prescribers of opioids to complete additional training regarding the special risks of substance abuse and overdose in opioid medications,” said Senator Braun.

Both bills are also co-sponsored by Senator Joe Manchin (D-W.V.).

The mandatory education required by the Safe Prescribing of Controlled Substances Act would focus on best practices for pain management and alternative non-opioid therapies for pain, methods for diagnosing and treating a substance use disorder, linking patients to evidence-based treatment for substance use disorders, and tools to manage adherence and diversion of controlled substances, including Prescription Drug Monitoring Programs. The legislation also requires that the Department of Health and Human Services evaluate how implementing this new education requirement impacts prescribing patterns.

A copy of the Safe Prescribing of Controlled Substances Act can be found HERE.

The Safe Prescribing of Controlled Substances Act was previously supported by the American Public Health Association, American Society of Addiction Medicine, National Council for Behavioral Health, National Safety Council, and the Massachusetts Medical Society.

The LABEL Opioids Act would require the Food and Drug Administration (FDA) to issue regulations providing for a warning label to be affixed directly to the opioid prescription bottle handed to the patient by the pharmacist.  Despite increased awareness of the addictive qualities of prescription opioids, roughly twelve percent of patients prescribed an opioid for chronic pain develop an opioid-use disorder, and as many as 29 percent of chronic pain patients misuse prescription opioids. Utah, Arizona, and Hawaii have passed state laws requiring labeling of prescription opioids and legislation has been introduced in several other states. Canada has issued regulations to require opioid labeling nationally. Congressman Greg Stanton (AZ-09) reintroduced companion legislation in the House of Representatives.

A copy of the LABEL Opioids Act can be found HERE.

The LABEL Opioids Act was previously supported by the American Public Health Association, Community Anti-Drug Coalitions of America, National Association of County and City Health Officials, National Safety Council, Trust for America’s Health, and the Massachusetts Medical Society.

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