Since last August, America has been experiencing a severe shortage of Adderall and related stimulant medications used to treat attention deficit hyperactivity disorder. While the origin of the shortfall is contested, some blame rigid manufacturing quotas imposed by the Drug Enforcement Administration, which the agency hasn’t lifted despite increased diagnoses, insisting that the manufacturers have not used all of their existing allowances. The D.E.A. also has yet to provide a clear explanation of the shortage or to take emergency actions to help alleviate it.
The scarcity, which according to the Food and Drug Administration now involves the generic versions of the drug and not the brand name, has also been exacerbated by limits on supplies of all controlled substances to pharmacies, which were promised by distributors as part of opioid litigation settlements.
To make matters worse, the D.E.A. announced in February that it wants to end the pandemic-driven relaxation of telehealth rules that currently allow people who take drugs like stimulants and opioid treatment medications to get them regularly without requiring at least one in-person visit. The public has until March 31 to comment on these new rules.
These changes may seem unrelated, but they reflect an approach to drug policy that focuses on controlling supply — one that has backfired in fighting opioid addiction and overdoses and could lead to similar damage to people who use prescription stimulants.
To avoid repeating history, the regulation of medically used controlled substances should be transferred from the D.E.A., a law enforcement agency with no expertise in medicine, to the Food and Drug Administration, which specializes in health. Supply restrictions harm patients who depend on medications, while doing nothing to treat those who are addicted. Doctors must be able to make individualized choices about care and not be hindered by shortages.
The scarcity of A.D.H.D. medications is already affecting patients’ ability to work and study. A mother of an 8-year-old whose behavior at school had improved significantly with medication told NPR: “The minute we ran out of it, he was back to, you know, getting in trouble every day, getting up out of his seat. The teachers immediately noticed.” Adults describe losing focus on the job, and some have already been fired because of declines in performance.
This reduced ability to function echoes what was seen among chronic pain patients who lost access to opioids as the D.E.A. cracked down on doctors, many of whom stopped or reduced prescribing, fearing legal consequences.
But as the medical opioid supply contracted, the death rate skyrocketed. Overdose deaths rose as opioid prescribing quadrupled in the first decade of the 21st century, but more than twice as many people died from opioid overdoses in the following 10 years, when prescribing rates were falling back to pre-crisis levels between 2011 and 2021. At least two-thirds of all overdose deaths are now linked to illicitly manufactured fentanyl and similar synthetics, not prescriptions. In the past year alone, total overdose deaths topped 100,000.
This horror was predictable: Though avoiding unnecessary prescribing for new patients may reduce addiction risk, stopping existing prescriptions for people who have pain, addiction or both does nothing to treat their underlying problems. Consequently, as the D.E.A. shuttered “pill mills” and legitimate doctors cut back, people with addiction turned to street drugs, which can be many times more deadly than pharmaceuticals. Patients in pain whose doses were reduced or eliminated were found to have a rate of suicide three to four times higher than those who continued.
The D.E.A. has not succeeded at its mission. Its efforts are not associated with sustained changes in drug use, which has risen and fallen over the 50 years since it was created, even as the federal budget for the war on drugs exploded between 1981 and 2020 and as the D.E.A.’s own budget now stands at some $3 billion annually. The agency’s attempt to curtail opioid prescribing did not prevent the tremendous increase in opioid use. The D.E.A. did not respond quickly to the rise of street fentanyl and the worsening of overdose rates that it caused, nor has it been able to significantly decrease availability.
The agency has also been marred by allegations of misconduct and corruption and has been unable to properly account for hundreds of millions in spending on informants. Only once in its history has it completely eliminated a popular drug, methaqualone, from the black market. Law enforcement is simply not the right tool to use for health care, as we are starting to see as abortion is criminalized.
Perhaps in response to its failure to prevent the rise in prescription opioid misuse, the D.E.A. may be trying to avert a repeat crisis by keeping stimulant manufacturing quotas tight. But the current shortage of medication for existing patients will cause problems similar to those seen when the eventual opioid cutbacks hit pain care.
Addiction is often linked to attempts to self-medicate for symptoms of A.D.H.D. About half of adults with A.D.H.D. will suffer from a substance use disorder in their lifetime. It might seem logical to assume that giving children with A.D.H.D. addictive stimulants would escalate addiction risk — or, conversely, to presume that effective treatment of A.D.H.D. would lead to less illegal drug-seeking.
But for reasons that remain unknown, children treated with A.D.H.D. medication have similar odds of developing addiction compared with those who do not take meds. Some research suggests, however, that these medications can be helpful in sustaining recovery from addiction in people with A.D.H.D. by keeping the attention disorder in check.
Reducing the accessibility of medications to people whose doctors believe that they are benefiting is never a great idea — especially for a group that is already prone to self-medication. Manufacturing quotas need to rise to meet existing demand for stimulants — and opioid settlement agreements need to be adjusted so that they ameliorate the problem rather than worsen it.
“Targeting all patients who are on treatment, instead of directly targeting people of concern, it seems like we’re going to see the same thing that happened with opioids,” said Dr. Ximena Levander, assistant professor of addiction medicine at Oregon Health and Science University, explaining that patients who are suddenly cut off are likely to go to the streets.
Moreover, increasing telehealth restrictions on access to opioid treatment medications like buprenorphine — which is also one of the medications targeted for cutbacks by the settlement agreements and may soon require an in-person visit following a 30-day prescription — creates barriers to recovery, not to addiction.
Dr. Levander, who sees patients in rural Oregon, notes that there is little evidence that telehealth-only prescribing did harm during the pandemic. “Quite the opposite, it’s been really beneficial for access,” she said. Some of her patients live six hours away by car. “Where are these people supposed to go?” she said. “There aren’t primary care or addiction doctors that are available to see people within the first 30 days.”
The D.E.A. has had five decades to prove that it can do better than the F.D.A. in controlling potentially dangerous drugs used in medicine. It has failed. Medical experts should be in charge of regulating controlled substances, as they were before the D.E.A. was created. It would be cheaper and more effective than using law enforcement, even though funding would need to be boosted significantly to directly attack undue influence from pharmaceutical companies.
Meanwhile, the D.E.A. must drop the proposed new telehealth restrictions and ensure that quotas do not restrict legitimate access to controlled drugs. The last thing we need now is to incentivize the production of ever-more-potent street stimulants.
The post The Adderall Shortage Reflects Bad Drug Policy appeared first on New York Times.
