- The Other Opioid Crisis: How False Narratives Are Hurting Patients
- The Other Opioid Crisis: A Failure of Care
- The Other Opioid Crisis: How the Criminal Justice System Imperils Patients and Physicians
- The Other Opioid Crisis: Ethical Issues Surrounding Opioid Regulation
In most popular depictions of the “opioid crisis,” ranging from Hulu’s “Dopesick” to Stanford physician Anna Lembke’s 2016 book, “Drug Dealer, MD,” the driving force of the crisis is physicians—who in this narrative are helpless pawns of the pharmaceutical companies—overprescribing opioids. This narrative has been taken up and repeated by politicians, law enforcement and interest groups seeking solutions to the harms caused by substance use disorder.
This narrative has at best a tenuous link to reality. It is, however, deeply entrenched in culture and widely accepted as true. As a result of this narrative, combined with ambiguous statutory language in the Controlled Substances Act of 1971 and the poorly drafted 2016 “Guideline on Prescribing Opioids for Chronic Pain” from the Centers for Disease Control and Prevention (CDC), law enforcement has had an inordinate influence in medical decision-making, as physicians desperately sought to treat patients while protecting themselves from the threat of civil forfeiture and loss of livelihood.
Because of the Controlled Substances Act’s ambiguous language, there has historically been no legal definition of “overprescription.” So matters stood for half a century, until the Supreme Court handed down its unanimous ruling in Ruan v. United States in June 2022. The decision establishes a narrow definition of what constitutes overprescribing, leaving physicians with greater discretion in their medical decision-making. But the long-term effects of Ruan on law enforcement and physician behavior remain to be seen.
Law Enforcement Discretion and Physician Uncertainty
In the decades between the Controlled Substances Act and the Ruan decision, law enforcement agencies had extraordinary latitude in their hunt for “overprescribing” physicians. This high level of discretion affected not only how the Drug Enforcement Administration (DEA) pursued the so-called war on drugs for half a century, but also how medical decisions were made for both acute and chronic care, as physicians were uncertain what behaviors would run afoul of the agency and state and local law enforcement. The DEA persisted in its focus on prescribed opioids for medical use, even as illicit drugs flooded the nation and a vast majority of the skyrocketing fatal accidental overdoses were caused by a combination of street drugs and alcohol, not by prescription opioids.
The legal landscape is dominated by fear and increasingly adversarial relationships that should be cooperative. Physicians, pharmacists and patients have grown increasingly fearful of DEA investigation, particularly after the agency seized on the metrics provided by the CDC’s 2016 “Guideline on Prescribing Opioids.” Ruan offers some protection to physicians against DEA investigations, but civil forfeiture, as always, remains a stumbling block.
The Controlled Substances Act placed some important restrictions on the use of opioids and, just as importantly, explicitly did not place other limits. While heroin is a Schedule I drug, considered to have no accepted medical use, other opioids, such as morphine, oxycodone, hydrocodone and fentanyl, are Schedule II drugs with accepted medical uses. Schedule II drug manufacturers, distributers and dispensers (that is, pharmacists) are all required to register with the DEA. Physicians prescribing Schedule II drugs also require a DEA license. As the DEA intensified its hunt for illicit diversion of prescribed opioids, it added restrictions on how physicians could prescribe them, forbidding refills and imposing 30-day limits on prescriptions.
Each Schedule II prescription goes into a statewide database called a prescription drug monitoring program (PDMP). Currently, all 50 states have such databases, though they vary in scope. Most cover only scheduled drugs; Nebraska, however, includes all prescription drugs in its PDMP. In some states, a law enforcement agency manages the PDMP, while in others it can be a nonlaw enforcement agency such as the department of health. As of now, only 19 states require a warrant to access the PDMP; mere possession of a login and password is sufficient to acquire access to sensitive medical information in most states. Law professor Jennifer Olivia, a co-counsel for an amicus brief in Ruan, points out that modern PDMPs are increasingly sophisticated law enforcement surveillance tools.
Law enforcement uses data from PDMP to identify “high prescribers.” It is not quite clear how the DEA makes this determination. All too often, these physicians are pain management doctors, with a population of patients whose illnesses cause high-impact pain requiring long-term opioid therapy, so it’s unsurprising that they would prescribe more opioids than would, say, primary care physicians. Yet simply having a practice that treats such patients subjects these physicians to increased law enforcement scrutiny.
Bad Metrics and the Wrong Focus
One metric the DEA and other law enforcement seem to rely on is morphine milligram equivalents (MMEs)—a rough way to “account for differences in opioid drug type and strength.” MMEs were never intended to be averaged across patient populations, however. Definitions of MMEs are vague and overlapping, according to professor of pharmacy Dr. Nabarun Dasgupta. This makes MMEs very difficult to compare across patients. Furthermore, the FDA, the agency with congressional authority to oversee the safety of opioids and other Schedule II medications, has declined to put an MME cap on opioid prescriptions. The FDA’s position leaves dosing decisions with the physician and accounts for the vast variation in patient response to opioid therapy.
The CDC and the DEA, on the other hand, take a more interventionist stance. The CDC lacks authority to regulate opioids, so the best it can do is issue nonbinding guidelines. The 2016 “Guideline” recommends physicians to take extra care when prescribing above 90 MME, but law enforcement seized on the 90 MME metric as some sort of hard measure. Anything above that immediately became suspect. Even one patient with a “high” prescription level could trigger an investigation of a physician or medical practice. After 2012, when opioid prescription numbers peaked, physicians increasingly practiced with fear of law enforcement, because the rules were never quite clear. In an excess of caution, patients with high-impact pain, who are a relatively small part of the population but who use most of the opioids prescribed, were rapidly tapered off. The effects on patients were disastrous.
The DEA continues this hunt for “drug-dealing doctors” even today, despite the fact that there is very little diversion of drugs from medical channels and almost none from patients. On the contrary, patients across the board are having their pain relief options limited, including patients with cancer where opioids are the first-line treatment.
The opioid problem today is a lack of access and even temporary shortages of some pain relievers. But in the 1990s, the DEA actually contributed to the rise of pill mills and the flow of prescription pain relievers to illicit markets. In what is probably a unique feature of the U.S., the DEA, a law enforcement agency, determines the quantities of the various Schedule II opioids—prescription medications—that manufacturers can produce in a year. The DEA increased the quota of oxycodone by about 3,900% between 1993 and 2015; the quota for fentanyl increased by 2,500%. While some increase was necessary as pain was significantly undertreated in the 1990s, opening the floodgates to this degree was a questionable call at best. The 1990s saw the rise of the pill mills and the first wave of the crisis, as a significant share of the new opioid production was diverted to nonmedical use.
The rates of substance use disorder have remained largely stable over the past several decades. The drug du jour has changed, though, with changes in the legal landscape. Sharp cutbacks in prescribing began in 2012, starting with the Veterans Administration, where prescriptions fell by two-thirds in eight years. The DEA started cutting opioid quotas in 2015. As the supply of prescription opioids in the illicit markets shrank, first heroin, then illicit fentanyl analogs filled the gap. The number of prescriptions fell rapidly between 2012 and 2022, but the number of fatal accidental overdoses rose almost as fast.
Today, opioid prescriptions are about 60% lower than their all-time peak in 2012. Fatal accidental overdoses, however, are at an all-time high, exceeding 100,000 last year. About 85% of these fatalities were caused by a combination of substances, including alcohol and illicit fentanyl analogs—substances that were never part of the medical materials supply chain. The DEA nonetheless continues to persist with its narrative of overprescribing doctors.
Just to underscore what seems like an increasingly Kafkaesque world, the DEA announced a special task force targeting medical prescribers in New England on June 29—two days after the Supreme Court handed down the Ruan decision. New Hampshire, one of the states included, had just three fatal overdoses where opioids were implicated, out of a total 230 fatal accidental overdoses in 2022. Total fatal accidental overdoses actually declined in New Hampshire from 414 in 2020 to 230 this year, which makes the need of the task force even more inexplicable.
Ruan’s Relief: Interpreting “As Authorized”
The Controlled Substances Act states that physicians are allowed to dispense Schedule II drugs as long as the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” The act also says: “Except as authorized[,] . . . for any person knowingly or intentionally . . . to manufacture, distribute, or dispense . . . a controlled substance” is a federal crime (emphasis added).
Before Ruan, the DEA claimed that the appropriate standard for evaluating “authorization” was what a reasonable doctor would do. If, in the DEA’s judgment, the number of a physician’s opioid prescriptions was higher than what a reasonable doctor would prescribe, the DEA could prosecute the physician and even seize his or her assets. The Supreme Court rejected this argument, vacating the conviction of two physicians for dispensing controlled substances not “as authorized.” The court held that the provider must dispense the medication “knowingly or intentionally” without authorization to be in violation of the Controlled Substances Act. If charged, once the defendant provider has shown evidence of authorization to dispense, the prosecutor must prove beyond a reasonable doubt that the defendant knowingly or intentionally did so beyond the scope of authority conferred by the statute.
In Ruan, the court provided both clarity and a higher bar for conviction. In the majority opinion, Justice Breyer raised the concern of overdeterrence of beneficial behavior. The rapid forced tapers, patient abandonment, loss of healthcare providers in inner cities and rural areas, and other unfavorable outcomes are slowly being studied and documented. Ruan is hopefully a turning point in this disastrous war against physicians that has left patients with incurable diseases and chronic pain as collateral damage. Just days after the Ruan opinion was handed down, four physicians in Michigan who had been battling overprescription charges for years were found not guilty.
It now remains to be seen if the DEA will take the Supreme Court’s decision seriously, or if it will continue to expend taxpayer monies in search of “overprescribing” physicians, even though nonmedical use of prescription opioids is a far less urgent problem than illicit fentanyl analogs flooding the nation from overseas. Ruan offers a shield, but as long as the DEA can use civil forfeiture as a sword, medical providers will rightfully remain wary. So it remains to be seen what, if any, comfort healthcare providers draw from the decision, and how it affects medical decision-making in prescribing.