FDA Approves New Labeling on Opioid Drugs

Last week, the U.S. Food and Drug Administration (FDA) approved drug label updates for prescription opioids. As stated in a news release about the update, the FDA revised labels to help healthcare professionals more appropriately and safely prescribe opioid drugs.

The boxed label highlights the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS), which aims to better express the risks of using opioids to both patients and industry professionals. The new REMS applies to immediate-release opioid analgesics for outpatient use, in addition to the extended-release and long-acting opioid analgesics that have been impacted by a REMS since 2012.

The strategy will encourage providers to participate in an educational program to ensure they are safely administering opioids to patients for acute pain management, as well as counseling patients on safely taking, storing, and disposing of the medication. It will also encourage patients and caregivers to read medication guides when they are provided by pharmacists. Drug safety labels were updated to reflect the REMS for medications such as codeine, demerol, dolophine (methadone), fentanyl, morphine and oxycodone.

The FDA noted that making these updates were a top priority, as opioid use rises and the opioid crisis itself continues. They hope to roll out a mandatory educational training program in the future, to add to the FDA black box warning. Opioids were responsible for more than 72,000 deaths in 2017, making this warning instrumental in the fight against addiction.

Why Opioids Need a Boxed Warning

The update comes as a necessary defense against the opioid epidemic, as a 30% increase in opioid overdoses was reported in the United States from July 2016 to September 2017. Although effective at treating both acute and chronic pain, it is no secret that opioids come with serious, and sometimes fatal, side effects that may outweigh the benefit for some users. Along with physical effects like nausea and vomiting, individuals may also experience mood swings, depression, panic attacks, and potentially more severe withdrawal symptoms and lasting health problems.

Drug addiction serves as the biggest risk factor in opioid use, particularly heroin, according to the National Institute on Drug Abuse. Seventy-five percent of those who are addicted to heroin reported that the addiction began with legally prescribed opioid medications. Many times, these severe addictions lead to overdose deaths.

With an increase in overdose cases, and drug use nationally, comes an uptick in both government and individual opioid lawsuits. Thousands of these lawsuits note that doctors, pharmacists, and even the manufacturers themselves are failing to warn patients and caregivers about the potential dangers of opioids. The new labels aim to provide the warnings and information that should have been present all along in order to lower the risk of addiction and limit further damage from the epidemic.

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What the Changes Mean for Patients and Doctors

Included in the strategy is a list of steps healthcare providers are encouraged to take to better protect patients, such as completing a REMS-compliant education program. The continuing education (CE) program will detail how to assess whether a patient needs an opioid to treat pain, how and when to modify doses or discontinue use, and help develop a better understanding of the signs of drug misuse, addiction, and abuse. This training will now be available to all health professionals involved in the process of helping patients manage pain, including pharmacists and nurses, to help protect patients and reduce the number of opioid addictions and overdoses.

A vital part of responsibly handling opioid medication, and another point that the strategy notes, is proper disposal of prescribed pain medication. Each year, the U.S. Drug Enforcement Administration (DEA) sponsors a National Prescription Drug Take-Back Day to ensure responsible disposal of prescriptions. Take-back day is an easy way to get rid of old prescriptions, but the REMS also encourages healthcare professionals to inform patients about other safe ways to remove them from homes and keep them out of the hands of others. The FDA recommends not flushing any drug down the sink or toilet, but instead mixing it with an undesirable substance and throwing it in the trash in an unsealable bag.