Emergency’s end could curtail virtual prescribing

From: POLITICO Future Pulse - Thursday Jan 12,2023 07:01 pm
The ideas and innovators shaping health care
Jan 12, 2023 View in browser
 
Future Pulse

By Ben Leonard, Carmen Paun, Erin Schumaker and Ruth Reader

THE REGULATORS

Drug Enforcement Agency logo is pictured.

The DEA has considered allowing virtual prescribing of controlled substances for years. | Getty

The Covid public health emergency, which looks increasingly likely to end as soon as April, could curtail access to drugs used to treat substance use disorders and mental illnesses.

Why? Pandemic waivers allowed people with substance use disorders and mental health conditions to obtain prescriptions via telehealth visits for controlled substances safeguarded by the Drug Enforcement Administration, which have traditionally required in-person doctor visits to get.

Congress extended many telehealth rules spawned by the pandemic in the year-end funding bill but not DEA rules on virtual prescribing of controlled substances.

Could the DEA act between now and April?

Maybe. The Biden administration has said in its newly released policy agenda that it expects to issue a proposed rule this month to facilitate virtual prescribing of buprenorphine — a drug used to treat opioid use disorder — and a separate regulation permitting access to controlled substances by telemedicine.

But the DEA has mulled virtual prescribing since Congress directed it to do so in a 2008 law and the agency has missed two congressional deadlines to set up a special registration process to allow for it. Shawn Ryan, chair of the American Society of Addiction Medicine's legislative advocacy committee, suggested that the eased regulations could be extended through the opioid crisis public health emergency, which has been in place since 2017.

Tasked with preventing drug misuse, the DEA is concerned that some virtual prescribers abused pandemic waivers to overprescribe medicine. It’s reportedly investigating two firms, Cerebral and Done, for allegedly overprescribing controlled substances used to treat attention-deficit hyperactivity disorder.

The DEA alleged last month that Truepill, which served as the pharmacy for virtual mental health care firm Cerebral, doled out controlled substances without a legitimate medical purpose. According to The Wall Street Journal, Truepill’s CEO said the firm is cooperating with the DEA and is “confident we will be able to demonstrate the absence of wrongdoing.”

The agency declined to comment on its post-Covid emergency plans.

What’s at stake?

The need for effective treatment of substance use disorder and mental illness is immense.

HHS’ Substance Abuse and Mental Health Services Administration said last week that its 2021 survey found that more than 15 percent of the population, about 46 million people, had a substance use disorder, and about 1 in 4 adults had a mental illness.

And while the number of people seeking mental health care is growing, SAMHSA said that nearly 94 percent of people with substance use disorder didn’t receive treatment in 2021.

Gender-affirming care providers like Plume and FOLX also hope that expanded access to virtual controlled substance prescribing stays intact. Otherwise, testosterone access would become more limited.

“Given the difficulty that many trans patients encounter finding safe, affirming care in their communities, that would present a significant hardship,” said Jerrica Kirkley, co-founder and chief medical officer of Plume.

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WORLD VIEW

Uganda's Minister of Health Jane Ruth Aceng receives boxes containing one of three candidate vaccines against the Sudan strain of the Ebola virus, in Entebbe, Uganda Thursday, Dec. 8, 2022. According to Uganda's Ministry of Health the country has received 1200 doses of vaccines from the World Health Organization to be used in an upcoming Ebola vaccine trial. (AP Photo/Hajarah Nalwadda)

Uganda Minister of Health Jane Ruth Aceng receives boxes containing one of three candidate vaccines against the Sudan strain of the Ebola virus last month. | AP

The Ebola outbreak in Uganda has ended with lessons for public health officials on rapid vaccine deployment.

Though the World Health Organization and vaccine developers rushed to get three vaccine candidates to the central African country, the 2.5-month lag between the beginning of the outbreak in September and their arrival last month proved too long.

Health officials didn’t have enough time to test any candidate.

It was a missed opportunity, since outbreaks of the Sudan strain of the virus tend to be rare. The previous Sudan strain outbreak occurred a decade ago.

“We need to be sure there is an internationally held reserve of filled and finished, ready-to-deploy vaccine candidates that can be deployed for a trial as soon as an outbreak starts,” said Nicole Lurie, the executive director for preparedness and response and U.S. director at the Coalition for Epidemic Preparedness Innovations, which is involved in the development of the shots.

Even so: The shots’ deployment was far faster than during a West African outbreak of Ebola’s Zaire strain between 2013 and 2016. That outbreak lasted long enough to successfully test a vaccine — at the cost of 11,000 lives.

But the developers of the three shots for the Sudan strain — the Sabin Vaccine Institute, nonprofit research institute IAVI and a group of scientists at Oxford University — didn’t have enough doses to deliver, and the WHO and Ugandan officials took months to work out regulatory and logistical matters.

The toll: The virus killed a large share of the people known to have been infected, with 55 confirmed deaths and 164 cases since September. The Ugandan government locked down several districts at the outbreak’s epicenter to stamp out the deadly hemorrhagic fever.

What’s next? Experts discussed how to speed up vaccine distribution at a meeting the WHO organized today. Ana Maria Henao-Restrepo, the WHO co-lead of the R&D Blueprint for epidemics, said countries need:

— a clinical trials platform that’s ready to go in all countries at risk of an outbreak

— candidate vaccines in vials

— regulatory and ethics requirements preapproved

— flexible funding set in advance

DANGER ZONE

BOSSIER CITY,LA-SEPTEMBER 11: A Glock 9mm pistol, legal to own under present guns laws, is displayed with 2 different capacity bullet clips at Shooters USA target range on September 11, 2004 in Bossier City, Louisiana. The top clip holds a total of 10 bullets currently legal, the bottom clip 18 bullets, is only legal for law enforcement officers. When the Assault Weapons Ban expires at midnight Monday September 13 the 18 round high capacity magazine will be legal to purchase. (Photo by Mario Villafuerte/Getty Images)

An estimated 4.6 million kids lived in a home with at least one unlocked and loaded firearm in 2021. | Getty Images

The shooting of a teacher in Newport News, Va., by a 6-year-old student has renewed concerns about safe gun storage and what responsibility — both ethically and legally — parents have in preventing such shootings.

The 9mm handgun the student took from home was owned by his mother and legally purchased, according to authorities. It's not yet clear how the gun was stored, but the American Academy of Pediatrics recommends gun owners who have kids store firearms unloaded and locked, with ammunition in a separate secure location.

A recent spike in gun purchases, including among first-time gun buyers, means 7 million more kids are living in households with guns. The trend may have deadly consequences. Firearm deaths surpassed motor vehicle deaths in 2020 as the leading cause of death for children in the U.S., according to CDC data.

What to know about kids and guns in America: 

— 11 school shootings since 1999 were perpetrated by children 10 and younger, according to an analysis by The Washington Post. The median age of school shooters is 16, the Post found.

— Twenty-three states and the District of Columbia have laws on the books requiring guns to be safely stored when not in use, according to the Giffords Law Center. While those laws vary from state to state, some hold gun owners liable if they fail to keep their guns out of the hands of minors.

— An estimated 4.6 million kids lived in a home with at least one unlocked and loaded firearm in 2021, according to a survey published last year in JAMA Network Open.

— Gun owners with kids in that 2021 survey were more likely to say they stored all household guns locked and unloaded (44 percent), than gun owners with children in a similar 2015 survey (29 percent).

 

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