“Online prescribing rules for controlled drugs were relaxed three years ago under emergency waivers to ensure critical medications remained available during the COVID-19 pandemic. Now, the U.S. Drug Enforcement Agency has proposed a rule that would reinstate most previously longstanding requirements that doctors see patients in person before prescribing narcotic drugs such as Oxycontin, amphetamines such as Adderall, and a host of other potentially dangerous drugs.
The aim is to reduce improper prescribing of these drugs by telehealth companies that boomed during the pandemic. Given the ongoing opioid epidemic, allowing continued broad use of telemedicine prescribing “would pose too great a risk to the public health and safety,” the proposed rule said. It also cracks down on how doctors can prescribe other less-addictive drugs, like Xanax, used to treat anxiety, and buprenorphine, a narcotic used to treat opioid addiction.
The rule would allow some of these drugs to be prescribed with telemedicine for an initial 30-day dose, though patients would need to be seen in person to get a refill. And patients who have been referred to a new doctor by one they had previously met in person could continue to receive prescriptions for the drugs via telemedicine.
DEA Administrator Anne Milgram called the plan “telemedicine with guardrails.”
The agency, with input from the Department of Health and Human Services, is working to finalize the rule by May 11, when the COVID public health emergency officially ends, an HHS spokeswoman said. If approved by then, the new requirements would take effect in November. [..]
“They completely forgot that there was a population of people who are dying,” said Dr. Lonny Shavelson, a California physician who chairs the American Clinicians Academy on Medical Aid in Dying, a coalition of doctors who help patients access care under so-called right-to-die laws. [..]
The clash between desperate patients who need treatment and DEA’s efforts to bar telehealth companies from overprescribing dangerous medications was inevitable, said David Herzberg, a historian of drugs at the University of Buffalo.
“The balancing act is so tricky,” he said.
Laws in 10 states and Washington, D.C. allow dying people with a prognosis of six months or less to end their lives with a lethal combination of medications covered by the DEA rule. But such patients are often too sick to visit a doctor in person ¬– or they live hundreds of miles from the nearest willing and qualified provider, Shavelson said.
There are similar issues for the 1.7 million Medicare recipients enrolled in hospice care in the U.S., said Judi Lund Person, who oversees regulatory compliance for the National Hospice and Palliative Care Organization. Rolling back online prescribing flexibilities could mean a dying patient would wait for days for drugs to ease pain and other symptoms.
“They just don’t have time for that,” she said.
Shavelson and his colleagues called for an exception to the rule for the hundreds of patients a year who qualify for medically assisted suicide. Both the American Medical Association and the California Medical Association sent letters asking the DEA to carve out provisions for doctors prescribing the most dangerous category of drugs to patients receiving hospice or palliative care. [..]
Congress directed DEA in 2008 to create exceptions for certain providers to permit remote prescribing, but the agency has not done so, Virginia Democrat Sen. Mark Warner said in a statement last month.
DEA officials did not respond to questions about whether COVID-19 telehealth waivers would remain in effect if the proposed rule isn’t finalized by May 11 or whether the agency will allow exceptions for remote prescribing.
During the pandemic, prescriptions for medically assisted suicide went up, in some cases significantly. In Oregon, for instance, they climbed nearly 49%, to 432 in 2022 from 290 in 2019. The number of deaths under the law in that state rose, too, to 246 from 170. Nationally, at least 1,300 people die each year using the process, according to available state figures.”
Full article, J Aleccia, STAT News, 2023.4.23