Dr. Scott Gottlieb, the new Commissioner of the U.S. Food and Drug Administration (FDA), is all prepared to take effective measures to control the opioid epidemic. In an email sent to all of his colleagues in May 2017, he chalks out the immediate steps to achieve the goal of public health. He affirms that FDA will continue to play an important role in addressing the crisis of opioid addiction and bringing a significant reduction in the number of new cases is their immediate priority.
In his first blog, “FDA Commissioner asks staff for “more forceful steps’ to stem the opioid crisis,” published in the official blog, FDA Voice, he emphasizes that FDA’s regulatory tools and societal obligations together can restrict the exposure to opioids and make it available for patients only if it is medically needed under clinical circumstances.
3 key questions for the Steering Committee
Dr. Gottlieb recommends that opioids should be prescribed only for the durations that match their clinical condition. He warns practitioners against unnecessary prescribing that may expose patients to prolonged use, thereby increasing the risk of addiction. Furthermore, the FDA commissioner also advises health care providers to consider broader public health implications of opioid use while writing their prescriptions.
As the first step, the commissioner talks about establishing an “Opioid Policy Steering Committee” comprising some of the most senior career leaders, who would be exploring and developing effective tools or strategies to help FDA fight the crisis. The Committee will address three major concerns or questions, in addition to other additional concerns that FDA might confront in due course of time. The pivotal role of the Committee will be to gather information and engage the public.
The first question that the Committee will need to answer is if there are circumstances that would require FDA to provide health care professionals with some form of mandatory education. This will aim at ensuring that doctors are well-versed with appropriate prescribing recommendations, possess knowledge for getting addicted patients into treatment and understand the ways to identify the risk of abuse.
The second question is directed towards exploring if FDA should take additional steps to ensure that the number of opioid doses prescribed to an individual patient meets the medical indication. For example, a 30-day supply is required only in a few situations and not by everyone. He advised doctors to make sure these situations are properly investigated before writing the prescription. The FDA emphasizes on the need of working more closely with health care providers to ensure that opioid prescription standards are followed in different clinical settings.
In the third question, Gottlieb asks the committee to see if FDA is employing appropriate policy framework relevant to the risk of abuse and misuse in tandem with the drug review process to approve medicines. The FDA should review their practices to assess if they are doing enough to evaluate new opioids for market authorization. They should also consider the possibility of framing new policies, if required.
The FDA acknowledges that despite a lot of efforts, opioid misuse is growing continuously, involving staggering human and economic costs. According to the Centers for Disease Control and Prevention (CDC), over 1,000 people receive treatment for misusing prescription opioids in emergency departments each day. Moreover, more than 33,000 deaths in the United States in 2015 involved opioids. However, hopes are alive that new prescription control interventions may be useful in bringing the situation under control, particularly in a scenario when the majority of people develop addiction to opioids after first taking them as prescribed by their doctors.
Treating prescription drug abuse
While the FDA and other state bodies do their bit in helping individuals live an addiction-free life, those addicted to prescription drugs can be treated with medical interventions, that includes medication, behavioral therapy or a combination of both. The Florida Drug Addiction Helpline is a useful online resource to seek information related to treating drug abuse and addiction treatment in Florida. Chat online or call our 24/7 helpline 855-982-2401 to find details about the best drug rehab programs in Florida.