We are overwhelmed with crises: environmental, political and even contagious. While these may have pushed the fatal opioid overdose crisis into the daily news, and perhaps into the public mind, the problem has not diminished – indeed, the opioid crisis is worse than never. In 2020, approximately 70,000 Americans died from an opioid overdose. That’s about one person every 7 minutes. This is the highest number ever recorded.
Opioid-related deaths in 2020 increased 30% from the previous year, continuing the decade-long trend of skyrocketing opioid overdose rates. The COVID-19 pandemic has only exacerbated the problem. The current opioid problem has been described as the “worst drug epidemic in American history.” It cost the U.S. economy more than $2.5 trillion between 2015 and 2018, including about $700 billion to $1 trillion in 2018 alone, in lost income and costs related to health care, loss of productivity, criminal justice and reduced quality of life.
Keep in mind that the opioid crisis is rooted in the pain epidemic. Pain affects 40 to 100 million American adults. It is the costliest public health problem in the country, exceeding the combined annual costs of heart disease, diabetes and cancer. Factors such as social isolation, unemployment, deteriorating mental or physical health, reduced access to emergency medical and addiction treatment services, and disruption of prescription drug supply chains aggravate crisis. More recently, it has been exacerbated by the abundant availability of illicit fentanyl.
A crucial reason for the opioid overdose problem remains the pool of unused prescription opioid pills, which are available for misuse or diversion by patients, friends or family. The diversion can be well-intentioned (wanting to help others in pain), or it can be stealing or selling pills to others.
To address the opioid epidemic in the United States, a storm of government and institutional policies and directives have been enacted, focused primarily, if not exclusively, on reducing opioid prescribing and restricting the offer. While opioid prescribing in the United States has decreased by 38% Over the past decade, however, opioid-related deaths have increased by 300%. This has been called the “opioid paradox” and is poorly recognized. The opioid paradox illustrates the reality that restricting opioid prescribing alone has not succeeded. Additionally, tight restrictions on opioid prescriptions can take painkillers to people who need them, while leaving illicit “street” supplies available. These patients may turn to illicit, but available and less expensive, supply chains as sources of opioids, such as fentanyl, a notoriously deadly substitute.
A necessary new approach
New approaches are needed to medical care, opioid prescribing, managing the nation’s opioid supply, and reducing the pool of unused opioids in medicine cabinets across America. We offer a totally new concept – “the prescription opioid ecosystem” – to tackle the opioid crisis and the opioid paradox. This concept goes far beyond simply restricting opioid prescribing to encompass a comprehensive, multi-part approach to reducing and better managing the prescription opioid pool. This involves immediate actions to address opioid use, stockpiling, return and harm reduction, with a particular focus on patients and communities.
The ecosystem concept illustrates that the size of the opioid pool is influenced not only by supply (prescription), but also by demand (patient need) and, most importantly, by the return or disposal of unused drugs. . Ecosystem management can be thought of as a “pool reduction strategy” to reduce demand, optimize supply, and increase the removal or return of opioids.
The first objective of the new ecosystem is to reduce the demand (need) for opioids, i.e. to improve the treatment of pain. Anesthesiologists and pain specialists know that most surgical patients report that their postoperative pain is not adequately treated. Additionally, many of these patients suffer from chronic post-surgical pain that can last for months after surgery. Persistent post-surgical pain begins with acute, undertreated pain that causes suffering and may be a risk factor for opioid abuse.
One of the biggest challenges is the inter-patient variability in postoperative pain, pain relief, and opioid use after surgery. We should avoid using “one size fits all” prescriptions or arbitrarily withholding needed opioids. Precision pain and opioid therapy should be the goal, with the goal of having to prescribe less on-the-go opioids.
The second objective of the new ecosystem is to reduce the “leftovers”. Hundreds of millions of opioid pills are dispensed to patients but not used every year. Most are just kept by the patients. Few pills are safely stored and only a fraction are discarded or returned. The risk is that patients use them in the future, often for a reason other than that for which they were prescribed, or that they misuse them. There is also the risk that they will be misused, misused by others and have catastrophic consequences.
We suggest that the whole concept of “giving” opioids to patients be replaced with “lending” them until they are no longer needed. Then, patients must “return” them when they are finished. This would reduce the size of the opioid pool.
It is remarkable and unfortunate that it is currently so difficult to return unused prescription opioids. This contrasts sharply with the ease of obtaining them. It is illogical and dangerous. The healthcare system must make it as easy or easier to return opioids than to receive them. Even better, research suggests that opioid redemption is likely to be very effective.
We suggest new regulations that would require pharmacies dispensing opioids to provide a) instructions for proper return/disposal (preferably on the label, not in paper form); b) addresses/telephone numbers of drug disposal stations; and c) a pre-addressed, prepaid envelope for the return of unused pills in a substance that would render them inactive and unusable if abused. The new ecosystem must integrate patient messaging, with an emphasis on the safe handling and storage of opioids. It should also emphasize that opioids are intended only for the recipient, only for the indication prescribed and only for as long as needed, and should then be returned or disposed of appropriately to minimize diversion, abuse and harm. .
Furthermore, it is crucial that patients be assured that their next episode of pain will be treated appropriately, lest they store up unused opioids lest such future pain and suffering go untreated.
The third goal of the new ecosystem is to change the way we distribute opioids, rather than just throttling the supply. This is done by partial filling of an opioid prescription. This would initially give patients less to take home, with fewer potential leftovers, and it would reduce the pool of unused opioids. But it would still allow patients with persistent pain to have it fully filled if needed, no questions asked and no additional cost.
Partial filling for Schedule III-IV (weaker) opioids has been allowed for decades. Remarkably, a federal law was enacted in 2016, the Comprehensive Addiction and Recovery Act, to allow partial fill for Schedule II (strong) opioids (like Oxycodone). But why has this not been systematically implemented and made available? Such a change in prescribing would have myriad potential benefits. This would give patients choice over their own care. This could reduce remaining opioids and the opioid pool by 540 million pills each year and save more than $656 million annually.
As we advocate for a fundamental overhaul of opioid policy and prescribing, and for the reduction of the prescription opioid pool, one caveat is that we must not repeat past mistakes with unintended consequences, especially for people who already have an opioid use disorder. Reducing the pool of prescription opioids will require expanding drug therapy programs for opioid use disorders.
The “Opioid Paradox” tells us that stifling the supply of opioids alone is not successful. The new paradigm of an opioid ecosystem, with its various components, offers the possibility of saving lives, improving health and reducing healthcare costs. This is a new concept inviting new approaches to controlling inappropriate access to opioids while maintaining availability for well-justified medical purposes.
Evan Kharasch, MD, PhD, is Merel H. Harmel Professor Emeritus of Anesthesiology at Duke University and editor of Anesthesiology, the peer-reviewed medical journal of the American Society of Anesthesiologists. David Clark, MD, PhD, is a professor of anesthesiology at Stanford University and the Palo Alto Veterans Affairs Medical Center. Jerome Adams, MD, MPH, is director of health equity at Purdue University and served as the 20th surgeon general in the United States.
Clark has a consulting agreement with Teikoku Pharma USA (San Jose, CA), which manufactures lidocaine patches. Kharasch and Adams declare no competing interests.