The Prescription Opioid Ecosystem: A Novel Approach to the Crisis

We are awash in crises: environmental, political, and even infectious. While these may have pushed the crisis of fatal opioid overdoses from the daily news, and perhaps the public mind, the problem has not been abated — indeed the opioid crisis is worse than ever. In 2020, approximately 70,000 Americans died from an opioid overdose. That’s about one person every 7 minutes. This is the highest number on record.

Opioid-related deaths in 2020 increased 30% over 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.” This cost the US economy more than $2.5 trillion between 2015 and 2018, including an estimated $700 billion to $1 trillion in 2018 alone, in lost lifetime earnings and costs associated with healthcare, lost 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 US adults. It is the country’s costliest public health problem — exceeding the combined annual costs of heart disease, diabetes, and cancer. Intensifying the crisis are factors such as social isolation, unemployment, worsening mental or physical health, reduced access to emergency medical and drug treatment services, and disrupted prescription drug supply chains. Most 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. Diversion may be well-intentioned (wanting to help others in pain), or it may be by theft or selling pills to others.

To address the US opioid epidemic, a blizzard of government and institutional policies and guidelines have been enacted, focused primarily if not exclusively on reducing opioid prescribing and restricting supply. While US opioid prescribing has decreased 38% in the past decade, opioid deaths have nonetheless increased 300%. This has been termed the “opioid paradox” and is poorly recognized. The opioid paradox illustrates the reality that restricting opioid prescribing alone has not succeeded. Moreover, tight restrictions on opioid prescriptions can take pain pills from people who need them, while leaving illicit “street” supplies available. Such patients may turn to illicit, yet available and less expensive, supply chains as sources of opioids — such as fentanyl, a substitute that is notoriously lethal.

A Much Needed 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 the medicine cabinets across America. We suggest a totally new concept – the “prescription opioid ecosystem” — to combat the opioid crisis and the opioid paradox. This concept goes far beyond simple restriction of opioid prescribing to encompass a comprehensive, multi-part approach to shrink and better manage the pool of prescription opioids. It involves immediate actions to address opioid use, storage, return, and harm reduction, with a specific focus on patients and communities.

The ecosystem concept illustrates that the size of the opioid pool is influenced not just by supply (prescribing), but also by demand (patient need), and, importantly, by return or disposal of unused drugs. Managing the ecosystem can be envisioned as a “pool-reduction strategy,” to decrease demand, optimize supply, and increase opioid disposal or return.

The first goal of the new ecosystem is to reduce the demand (need) for opioids — that is, to improve pain therapy. Anesthesiologists and pain physicians know that most surgical patients report that their postoperative pain is not adequately treated. In addition, many such patients experience chronic post-surgical pain that can last for months after surgery. Persistent postsurgical pain starts with undertreated acute pain, causes suffering, and can be a risk factor for opioid misuse.

One of the greatest challenges is interpatient variability in postoperative pain, pain relief, and opioid use after surgery. We should avoid using “one-size-fits-all” prescribing, or arbitrarily withholding needed opioids altogether. Precision pain and opioid therapy should be the objective, towards the goal of needing to prescribe fewer take-home opioids.

The second goal of the new ecosystem is to reduce “leftovers.” Hundreds of millions of opioid pills are dispensed to patients but go unused each year. Most are just kept by patients. Few pills are safely stored, and only a fraction are disposed of or returned. The risk is that patients may use them in the future, often for a reason other than what they were prescribed for, or they may misuse them. There’s also the risk they may be diverted, misused by others, and have catastrophic consequences.

We suggest the entire concept of “giving” opioids to patients should be replaced with one of “loaning” them until no longer needed. Then patients should “give them back” when finished. This would decrease the size of the opioid pool.

It is remarkable, and unfortunate, that it is currently so difficult to return unused prescription opioids. This contrasts markedly with the ease of obtaining them. This is illogical and unsafe. The healthcare system needs to make returning opioids as easy as or easier than receiving them. Even better, research suggests that opioid buy-back is likely to be highly effective.

We suggest new regulations that would require pharmacies dispensing opioids to provide a) instructions for proper return/disposal (preferably on the label, not as a handout); b) addresses/telephone numbers of drug disposal stations; and c) a pre-addressed, prepaid envelope for returning unused pills in a substance that would render them inactive and unusable for misuse. The new ecosystem needs to incorporate patient messaging, stressful safe handling and opioid storage. It also must emphasize that opioids are only intended for the recipient, only for the prescribed indication, and only for as long as needed, and then they must be appropriately returned or disposed of to minimize diversion, misuse, and harm.

In addition, it is crucial that patients are assured that their next episode of pain will be treated appropriately, lest they hoard unused opioids for fear that any such future pain and suffering will not be treated.

The third goal of the new ecosystem is to change the way we dispense opioids, rather than just strangling the supply. This is through partial filling of an opioid prescription. This would initially give patients less to take home, with fewer potential leftovers, and it would reduce the unused opioid pool. But it would still let patients with ongoing pain to have it fully filled if needed, with no questions asked and at no additional cost.

Partial filling for schedule III–IV (weaker) opioids has been permitted for decades. Remarkably, a federal law was enacted in 2016, the Comprehensive Addiction and Recovery Act, to permit partial filling for schedule II (strong) opioids (such as oxycodone). But why has this not been routinely implemented and made available? Such a change in prescribing would have myriad potential benefits. It would give patients choice in their own care. It could reduce leftover opioids and the opioid pool by 540 million pills each year, and save more than $656 million annually.

As we advocate for a fundamental rethinking of opioid policy and prescribing, and shrinking the prescription opioid pool, a caveat is that we must not repeat past mistakes with unintended consequences, particularly for those with existing opioid use disorder. Shrinking of the prescription opioid pool will require expansion of programs for medication-assisted therapy for opioid use disorder.

The “opioid paradox” tells us that choking the opioid supply alone is not succeeding. The new paradigm of an opioid ecosystem, with its various components, offers the possibility of saving lives, improving health, and reducing healthcare costs. It is a novel concept inviting novel approaches to controlling inappropriate access to opioids while maintaining availability for well-justified medical purposes.

Evan Kharasch, MD, PhD, is the Merel H. Harmel Distinguished Professor of Anesthesiology at Duke University and editor in chief of Anesthesiology, the peer-reviewed medical journal of the American Society of Anesthesiologists. David Clark, MD, PhD, is 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 was the 20th Surgeon General of the United States.

Disclosures

Clark has a consulting agreement with Teikoku Pharma USA (San Jose, California), which makes lidocaine patches. Kharash and Adams declare no competing interests.

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