Combatting Prescription Opioid Abuse

Patricia J. Zettler, associate professor of law, served as a consultant to the National Academies of Sciences, Engineering, and Medicine (NASEM) Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse. The report, which was commissioned by the U.S. Food and Drug Administration (FDA), was released in July. Zettler has expertise in the regulation of medical products, medicine and biomedical research, with an emphasis on the U.S. Food and Drug Administration (FDA). She is a former associate chief counsel in the FDA’s Office of Chief Counsel.

How bad is the opioid crisis? 
Drug overdose is the leading cause of accidental death in the United States, driven largely by overdose related to opioid use. On average, 90 individuals in the United States die each day from an overdose that involves an opioid. Trends indicate that premature deaths associated with the use of opioids are likely to climb, and overdose and other opioid-related harms are likely to significantly reduce quality of life for many for years to come.

What are some of the key findings of the report? 

Patricia Zettler

Patricia Zettler

The committee was asked to characterize the opioid epidemic and recommend actions that the FDA and other organizations should take to respond.

The report lays out several key elements for a successful response to the opioid crisis. These include changing the culture of prescribing, partially through enhancing education for physicians and the general public; investing in treatment for the millions of individuals with opioid-use disorder and removing impediments to those treatments; preventing overdose deaths, including by improving access to naloxone and safe injection equipment; incorporating the societal impacts of opioids into regulatory decisions; and investing in research, particularly in better understanding the nature of pain and developing nonaddictive alternatives to opioids for pain management.

Did the report discuss how opioids should be prescribed? 
The committee found that, despite a recent decrease in the number of opioid prescriptions, opioids are still being prescribed much more frequently for chronic noncancer pain than is warranted.

The report called for improved education for health care providers, including basic training in the treatment of opioid-use disorder for physicians, nurses, pharmacists, dentists, physician assistants, psychologists and social workers.

How will better access to naloxone help? 
The provision of naloxone to overdose victims by health professionals in the pre-hospital setting is the standard of care. Specifically, the report determined that mechanisms for increasing naloxone prescribing and dispensing, equipping first responders and possibly enabling over-the-counter status, are warranted. The report, however, also acknowledged that these goals may be impeded by high and unpredictable medication costs. The cost of naloxone is a key consideration and can be a major impediment to access to branded naloxone products.

What actions can the FDA take to address opioid misuse? 
The report recommended that the FDA incorporate broad public-health considerations into its opioid-related regulatory decisions. The FDA traditionally has taken a product specific approach to drug approval decisions by focusing on the data generated and submitted by a drug’s manufacturer and balancing the benefits against the risks to the individual patient. Although this approach works well in most cases, opioid medications should be viewed differently than many other drugs because, in addition to risks and benefits for the individual patient, these medications can have social externalities.

What will it take — and how long — to fix the problem?
It is important to keep in mind that the opioid crisis took nearly two decades to develop, and it will take many years to control and reverse. Therefore, years of a sustained and coordinated effort will be required to address the problem.

What else needs to be studied to further combat this crisis? 
The report’s first recommendation highlights the need to invest in research to better understand pain and opioid-use disorder. Chronic pain and opioid-use disorder represent complex human conditions affecting millions of Americans. Little is known about why some individuals who use prescribed opioids to alleviate pain develop opioid-use disorder. Research is needed to improve our understanding of opioid-use disorder, the nature of pain and the relationships among pain, opioids and the brain’s reward pathways. Such research can help support the discovery of innovative and successful treatments, including nonaddictive painkillers and nondrug approaches.