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FDA Enacts New Drug Safety Regulations to Fight Against Opioid Epidemic

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Opioid Painkillers

The U.S. Food and Drug Administration took a great step on July 23, 2020, by changing drug safety regulations for opioid painkillers. The FDA now recommends that patients with prescriptions for opioids receive adequate counseling about naloxone, the overdose-reversing medication. These changes represent a significant shift in the fight against the opioid epidemic and overdoses.

The Scope of the Prescription Painkiller Crisis

The mass expansion of prescriptions for opioid painkillers began in the 1990s, and it still fuels the current crisis. In 2014, medical providers wrote around 244.5 million prescriptions for opioid painkillers. That amount of prescriptions is enough for every adult in the United States to have a bottle of pills. Following a major shift and strict prescribing guidelines restrictions, the number of prescriptions was down to 153.7 million in 2019.
The rise in prescription painkiller availability led to a corresponding rise in overdose deaths. From 1999 to 2018, over 232,000 people in the United States died due to opioid overdoses related to prescription painkillers. Overdose deaths were four times higher in 2018 than in 1999.
Chronic pain management is a real public health issue that has led to a significant increase in opioid abuse. In many cases, people start using opioids after receiving a prescription from their doctor to treat a medical condition. After a certain period of time, patients might increase their dosage due to physical tolerance, and, in many cases, the analgesic effect may also help decrease emotional pain.
Unfortunately, the development of tolerance causes the continuous need for additional drugs, which might cause many to turn to heroin or synthetic opioids instead. The euphoria, numbing effects, and fear of withdrawal become the primary fuel of an addiction.

New FDA Guidelines Aim to Prevent Prescription Opioid Overdoses

The new FDA guidelines update the drug safety regulations for prescription opioids. The most significant change is the requirement for providers to discuss naloxone with their patients. Naloxone (sold under the brand name Narcan) is known as an overdose-reversing medication. It is commonly administered as a nasal spray or injection. Naloxone binds tightly to receptors, blocking the effects of opioids in the brain. Furthermore, Narcan can rapidly knock the painkiller molecules off of the receptors. When given during an opioid overdose, naloxone can increase breathing rate and prevent overdose death.
The FDA rules include three major groups of patients who should receive counseling about the availability and use of naloxone:

  1. Patients being prescribed opioid pain relievers. Physicians should now discuss the availability of naloxone and consider prescribing it if a patient is at high risk of an opioid overdose. This includes patients who take benzodiazepines or other central nervous system depressants, who have a history of opioid use disorders, have experienced an opioid overdose in the past, or have household members (e.g., children) at risk of overdose.
  2. Patients prescribed medications to treat opioid use disorder. Patients on medication-assisted treatment for opioid abuse are at risk for overdose. Medication-assisted treatment involves taking other opioids like buprenorphine or methadone to replace opioid painkillers, heroin, or fentanyl. The new FDA guidelines state that healthcare professionals should “strongly” consider prescribing naloxone to people on medication-assisted treatment.
  3. Those who could be at a high risk of an opioid overdose. This category includes not prescribed opioid painkillers or medication-assisted treatment but may be at higher risk of overdose. For example, people who have experienced a past overdose or those in recovery from opioid use disorder might be at high risk.

This announcement also comes with a labeling change for prescription drugs. Now, any prescription opioid pain medication or medication to treat opioid use disorder must have a different label. Labels must state that a healthcare professional should discuss the availability of naloxone when beginning or renewing this treatment. This labeling change aims to educate patients about opioid painkillers’ risks and the importance of life-saving naloxone.

Moving Forward to End the Opioid Epidemic

This move by the FDA is a huge step toward finding a solution for this indiscriminative crisis. A crisis that continues to destroy lives and families. Rather than prescribing opioids in a “one size fits all” manner, physicians must understand each patient’s unique mental health and medical burden. This is an essential precaution when prescribing medications that alter a person’s mental state. Educating patients about the risks of prescription opioid painkillers allows them to choose how to manage pain. Offering naloxone to those at high risk of abuse and overdose can save lives.
However, FDA drug safety regulations are not the sole solution to the opioid epidemic. We need to continue to find actionable solutions for the problem of prescription opioid abuse.

One major piece of the puzzle is expanding access to medical detox programs. Medical detox allows patients to go through withdrawal in a safe, comfortable hospital environment. After detox, patients can take time to heal and get the treatment they need to address the root causes of opioid abuse. Recovery may include a variety of therapeutic forms to manage chronic pain without the use of addictive narcotics.
It is critical to invest resources and attention on providing accessible mental health care. Psychotherapy to address trauma, depression, anxiety, and other mental health conditions can significantly minimize the need for narcotics. Not only do these mental health problems perpetuate chronic pain, but they also make it more likely that a person will use opioid medications to numb emotional pain. Treating these unmet mental health needs must be a central part of comprehensive treatment for opioid addiction.

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