- Newly minted FDA Commissioner Dr. Scott Gottlieb is coming out swinging against the rising tide of opioid abuse, stressing the important role of population health management strategies and education in preventing unintentional addiction to controlled substances.
In his first FDA blog post, Gottlieb joins colleagues from across the healthcare system in urging providers to act as the first line of defense for patients who may be at higher risk of becoming dependent on painkillers.
“We know that the majority of people who eventually become addicted to opioids are exposed first to prescription opioids,” he said.
“I believe it is within the scope of FDA’s regulatory tools – and our societal obligations – to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients.”
To further his message, Gottlieb is establishing an Opioid Policy Steering Committee which will explore how to leverage public health resources, emerging research, and the clinical care system to reduce the staggeringly high number of patients whose prolonged exposure to prescription opioids transitions into long-term substance abuse.
Approximately three-quarters of individuals who began abusing opioids in the first decade of the 21st century started with prescriptions, he pointed out.
“This March, a study published in CDC’s Morbidity and Mortality Weekly Report, found that opioid-naïve patients who fill a prescription for a one-day supply of opioids face a 6 percent risk of continuing their use of opioids for more than one year,” Gottlieb added.
“This study also found that the longer a person’s first exposure to opioids, the greater the risk that he or she will continue using opioids after one, or even three years. For example, when a person’s first exposure to opioids increases from one day to 30 days, that person’s likelihood of continuing to use opioids after one year increases from 6 percent to about 35 percent.”
With input from the public and the scientific community, the Steering Committee will begin its work by addressing three potential steps forward for the agency and its partners.
The Committee will consider the possibility of developing mandatory opioid education for healthcare professionals aimed at sharing best practices for assessing the addiction risk of vulnerable patients and prescribing guidelines to limit unintentional exposure to addictive therapies.
The panel will also mull the possibility of creating standards that limit the prescription of 30-day opioid supplies for patients who may only need a few days of pain management after an acute injury or surgery.
Reducing the amount of available opioids for patients who do not need a larger supply of pills may also prevent unauthorized family or friends from accessing leftover medications. In 2011, the CDC found that more than half of abused prescription painkillers were obtained free from a friend or relative. Close to 5 percent were taken without asking the person for whom the medications were originally prescribed.
Lastly, the FDA will examine how to maximize its oversight authority and policy frameworks to consider the risk of abuse and misuse of new pharmaceuticals during the drug review process. Additional policies may be necessary to adjust the approval process to take these properties into account.
Gottlieb isn’t the only federal official eying enhanced education and patient-centered strategies as a way to curb the ongoing opioid crisis. CMS has recently come out strongly in favor of engaging the industry in a concerted effort to tighten prescribing habits and apply population health management techniques to identifying and caring for patients at risk of abuse or dependence.
In January, Shantanu Agrawal, MD and Kate Goodrich, MD, MHS urged the industry to consider the high toll of opioids on the Medicare population and expand efforts to educate patients and providers about the impact of painkillers.
“CMS wants beneficiaries, their families, and caregivers to know what opioids are, the risk associated with their use and the role opioids may play in pain management,” Agrawal and Goodrich said.
“Our primary aim is to ensure that patients, their families, and caregivers have a better understanding of how to work with providers to identify treatment goals and successfully manage pain using current, safe, effective, and accessible treatments; for many patients this may not include an opioid.”
CMS is also considering policy changes that may improve the situation, including requiring all Medicare Part D and Marketplace plan formularies to include naloxone as a covered medication, enhancing electronic monitoring of high-risk beneficiaries, and preventing approval for Part D plans that block access to medication-assisted treatment for opioid addiction.
Gottlieb’s attention to opioids so early in his tenure indicates that the substance abuse epidemic is likely to remain high on the FDA’s list of priorities for the foreseeable future.
“Working together, we need to do all we can to get ahead of this crisis,” said Gottlieb. “That’s why we’ll also be soliciting public input, through various forums, on what additional steps FDA should consider.
“I look forward to working closely with my FDA colleagues as we quickly move forward, capitalizing on good work that has already been done, and expanding those efforts in novel directions. I will keep you updated on our work as we continue to confront this epidemic.”