The Drug Enforcement Administration Should Not Erect More Barriers to Care

The following was submitted as a public comment to the Drug Enforcement Administration's proposed rule change, "Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation." (Docket No. DEA-407)

 

I oppose the Drug Enforcement Administration’s (DEA’s) proposed rule change.

If implemented, this rule change will harm patients. It will not reduce drug use. It will increase drug-related deaths.

1. The proposed rule change will harm patients.

The DEA may claim that this rule change will not affect “legitimate” prescribers and patients. This is incorrect. 

The public has submitted over 28,000 comments addressing the proposed change, many of them testifying to the immense difficulty chronic pain and attention-deficit/hyperactivity disorder (ADHD) patients already have in accessing medications they need. This is a relatively new problem for ADHD patients, who have been affected by a prescription stimulant shortage since August 2022.[1] The DEA is well-aware of the stimulant shortage problem.[2]

By further restricting access to Schedule II substances prescribed via telemedicine, the DEA would be cutting off a lifeline to millions of Americans who are not able to make physical trips to a doctor’s office, whether because they live in a rural area or have insufficient transportation, childcare responsibilities, inflexible work schedules, health challenges, or other circumstances that make a monthly doctor’s visit an undue burden.

The more stringent rules would also deter medical practitioners and pharmacists from prescribing and dispensing drugs that patients need. We can be certain of this because of how the DEA’s efforts to limit opioid prescribing and dispensing have harmed chronic pain patients and individuals seeking buprenorphine for opioid use disorder.[3][4] One of these patients is my 76-year-old mother, who suffers from chronic and debilitating arthritis and cannot find a doctor willing to prescribe anything stronger than Tramadol, a weak opioid that only works on her “good” days.

The rule change would exacerbate the already-existing barriers to patient care while doing nothing to reduce drug use or overdose deaths.

2. The proposed rule change will not reduce drug use or misuse.

The DEA argues that the rule change is necessary to prevent telemedicine from being used to improperly prescribe controlled substances and to prevent diversion of these substances to the illicit market.[5]

The proposed rule change will almost certainly reduce drug diversion.

But reducing drug diversion will not reduce drug use or drug-related deaths.

Today’s overdose crisis confirms the futility of diversion control. In response to a rise in deaths involving prescription opioids in the mid-2000s, the DEA cut the legal supply of these drugs. This successfully decreased diversion of prescription painkillers, but it utterly failed to reduce drug-related deaths.

The DEA’s supply-side efforts failed because for the thousands of people dependent on prescription opioids, the alternative to a safe supply of opioids wasn’t no opioids at all but rather opioids supplied by the illicit market. The unregulated drug market met demand first with heroin and then, around 2015, with fentanyl. There would be fewer overdose deaths today if people still had access to less potent, highly regulated prescription opioids.

It is possible that the trajectory of the overdose epidemic, from prescription opioids to illicitly manufactured fentanyl and counterfeit pills, surprised the DEA. Perhaps the agency truly believed that a supply-side intervention would reduce drug use. But it is genuinely incomprehensible that the agency’s leadership could still think that today.

3. The proposed rule change will increase incidences of drug-related deaths and other adverse events.   

If this rule change is implemented, thousands of Americans will turn to the unregulated drug supply.

The DEA knows the risks associated with unregulated drugs. On September 27, 2021, the DEA issued a public safety alert warning of the “sharp increase in fake prescription pills containing fentanyl and meth[amphetamine].”[6] The DEA listed oxycodone, hydrocodone, and amphetamines like Adderall as drugs commonly found to be counterfeits — all schedule II substances that the proposed rule change would limit access to.

Restricting the supply of legal, quality-controlled schedule II substances would increase demand for and exposure to unregulated counterfeit pills that are significantly more dangerous. Failure to recognize this basic fact would confirm critics’ claims that the DEA is ill-suited to the task of reducing drug use and addiction.

If the agency does understand the consequences of restricting the legal supply of in-demand substances but does it anyway, then it will have effectively abandoned its basic duty as a government agency to serve the public good.

In response to this line of argument, the DEA may insist that it is simply enforcing the laws enacted by Congress and that dissatisfaction with the agency’s actions should be addressed through legislative reform. This is an abdication of its moral duty to protect the public. It is also disingenuous because the DEA actively lobbies Congress to preserve current drug laws.

The rapid adoption of telemedicine is one of the few positive developments of the COVID-19 pandemic. The potential downsides to expanded use of telemedicine in the treatment of addiction, chronic pain, and mental illness are offset by the huge improvements made in patient access and health care delivery. The DEA is now attempting to take away these gains. Doing so would harm patients and increase demand for and exposure to unregulated and more dangerous drugs.

 

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[1] https://www.healthaffairs.org/content/forefront/increasing-stimulant-prescriptions-prevent-overdose-deaths-adderall-shortage.

[2] Examples of the DEA responding to media inquiries about the stimulant shortage, https://www.npr.org/sections/health-shots/2023/02/18/1157832613/adderall-shortage-forces-some-patients-to-scramble-ration-or-go-without and https://www.bloomberg.com/news/newsletters/2023-02-28/are-adderall-dea-quotas-contributing-to-the-shortage.

[3] Aneri Pattani, 2021, DEA takes aggressive stance toward pharmacies trying to dispense addiction medicine. NPR. https://www.npr.org/sections/health-shots/2021/11/08/1053579556/dea-suboxone-subutex-pharmacies-addiction

[4] Joshua Fenton, et al., 2022, Long-term risk of overdose or mental health crisis after opioid dose tapering, JAMA, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2793293.

[5] The DEA states: “Given the ongoing opioid epidemic at the time of publishing, DEA believes that allowing for the prescription of any schedule II substances or the general prescription of narcotic controlled substances as a result of telemedicine encounters would pose too great a risk to the public health and safety.” P.7, https://www.govinfo.gov/content/pkg/FR-2023-03-01/pdf/2023-04248.pdf

[6] https://www.dea.gov/press-releases/2021/09/27/dea-issues-public-safety-alert

 

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