SCOTUS ruled on opioid prescriptions. Here’s what you need to know.
Key Takeaways
The Supreme Court of the United States has ruled that doctors must show intent to mis-prescribe opioids in order to face criminal charges.
Despite the drop in opioid prescriptions in recent years, opioid overdoses and deaths are on the rise, largely because of street drugs.
The CDC’s position is that physicians can better serve patients by focusing on when to initiate and continue opioid treatment, what type and dosage of opioid to use, and how to address risk of drug abuse when prescribing opioids.
Several physicians have been convicted for unlawfully prescribing opioids in operations that the US Department of Justice (DOJ) has described as “pill mills” and “criminal enterprises,” one of which is responsible for at least one known customer death.
Two doctors who were tried and convicted for participating in these operations, Shakeel Kahn, MD, and Xiulu Ruan, MD, fought back in a case that reached the Supreme Court of the United States (SCOTUS).
The Court’s June 2022 ruling on this case may ultimately change the standards by which doctors may be criminally charged for mis-prescribing opioids.
For now, physicians who prescribe opioids may take the associated risks and benefits of opioids into consideration throughout the treatment process.
Xiulu Ruan v. United States
In the United States, it is illegal to “knowingly or intentionally…manufacture, distribute, or dispense…a controlled substance” unless authorized to do so. As medical doctors, both Dr. Ruan and Dr. Kahn were entitled to this practice (21 U.S.C. §841).
Still, a physician is legally obliged to prescribe controlled substances only for legitimate medical purposes while “acting in the usual course of his professional practice,” as stated in the Xiulu Ruan v. United States syllabus.[]
Drs. Ruan and Kahn both violated this rule by prescribing opioids outside of their usual practice and for illegitimate medical purposes. The US argued that Dr. Ruan prescribed opioids illegally—committing mail and wire fraud in the process—for personal financial gain, as per the US DOJ’s 2017 report.[]
Dr. Kahn also profited from selling opioids to customers. Some paid him up to $4,000 per month for highly addictive opioids.
With little evidence to prove that these customers had income that could afford them this expense, the DOJ concluded that they paid for the drugs with the money earned from selling them to others.
The US DOJ reported that Dr. Kahn would target addicts in his quest for customers.[] The drugs he prescribed eventually reached a woman named Jessica Burch, who died from an overdose.
Years after both doctors began serving federal sentences exceeding 20 years, they urged the SCOTUS to take a closer look at the fine print of 21 U.S.C. §841 in a new case.
In June 2022, the court unanimously ruled in favor of Drs. Ruan and Kahn, stating that prosecutors who accuse doctors of running pill mills “must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.”
In other words, in order for a defendant to face criminal charges,the government must prove that the physician either intended for their prescriptions to be abused, or knew that they would be abused, according to an article published by the British Medical Journal.[]
The article’s author elaborated on the SCOTUS ruling’s potential domino effect, writing, “Several law professors and patient groups filed amicus briefs with the court arguing that the lack of a clear standard of guilt in opioid prosecutions had produced a chilling effect on responsible doctors, impacting both pain and addiction treatment.
"Opioid prescriptions have fallen in recent years, but overdose deaths continue to rise, now driven mostly by street drugs."
— Owen Dyer, British Medical Journal
Ethical guidelines for prescribing opioids
As legislation and research progress, so, too, does the CDC’s opioid prescription guideline.
The CDC’s updated opioid prescription guideline—informed by the latest research and including recommendations for acute, subacute, and chronic pain—will hit the website in late 2022. Until that occurs, here are a few factors doctors can consider when prescribing opioids:[]
When opioids should be used to manage chronic pain. In establishing the treatment goals for your patients with chronic pain, you may consider both non-pharmacologic therapy or non-opioid pharmacologic therapy, as well as an opioid. If opioid therapy is the right choice for your patient, discuss the benefits and risks ahead of time.
What type of opioid to prescribe, the dose, and the discontinuation process. Opioids are formulated asimmediate-release, extended-release, and long-acting products. In addition to the formulation, you will need to determine the most effective dosage for your patient and estimate the optimal duration of treatment. Schedule follow-up appointments with the patient so that you can check in with them and decide on the appropriate time to discontinue treatment.
Risks and harms associated with opioid use. When prescribing opioids, take your patient’s risk of opioid-related harms into account and consider ways to mitigate this risk. Consider using urine drug testing, data from prescription drug monitoring programs, monitoring for opioid interactions with benzodiazepines, and treatment protocols for opioid use disorder.
What this means for you
The SCOTUS just ruled that proof of intent to mis-prescribe opioids must be present for a doctor to be criminally charged. This ruling makes it easier for doctors to deviate from recommended practice under the law. If you and your patient decide to pursue opioid treatment, consider dosage, type of opioid, and the duration of treatment. Assess the risks related to opioid use and understand the potential treatment protocols for opioid use disorder.